NUCLEUS NETWORK LIMITED Clinical Trials List
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EARLY PHASE STUDIES
Sponsor Compound Type
No of Subjects
Route of Administration
Study Description Therapeutic Area Type of Subjects
US Biotech New Formulation
18 Oral A Double Blind Randomized Parallel Group Study to Evaluate the Tolerability of a New Extended Release (ER) Capsules in Healthy Elderly Volunteers
Neuroprotective - Alzhiemier's Disease
Healthy subjects
US Biotech New Chemical Entity
20 Oral A phase 1 Study in Subjects with Well Controlled Coeliac Disease to Assess the Effects of Gluten Digestion with a Protease Enzyme in Vitro.
Coeliac Disease Patients
US Big Pharma New Biological 6 SC Injection A Randomised, Double-blind, Placebo-Controlled, Multiple dose Study to Evaluate the Safety, Tolerability and Efficiency of a New Biological in Subjects with Psoriasis.
Dermatology- Psoriasis
Patients
US Big Pharma New Biological 72 SC Injection A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Biological in Healthy Subjects and Subjects with Moderate to Severe Psoriasis
Dermatology - Psoriasis
Healthy subjects
US Big Pharma New Biological 6 SC Injection A Long-term Assessment of the Safety and Efficacy of a New Biological Subcutaneous Treatment in Subjects with Psoriasis
Dermatology - Psoriasis
Patients
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NUCLEUS NETWORK LIMITED Clinical Trials List
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EARLY PHASE STUDIES
US Big Pharma New Biological 20 SC Injection A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of a New Biological After Multiple Dose Administration in Subjects with Moderate to Severe Psoriasis.
Dermatology - Psoriasis
Patients
US Big Pharma New Chemical Entity
40 Oral A Phase I, Randomized, Open-Label, Single-Dose, 2-Part, 4-Treatment, 4-Way Crossover Study in Healthy Adult Subjects to Evaluate the Pharmacokinetics of Various Formulations When Administered Under Fasted and Fed Conditions
Asthma Healthy subjects
US Big Pharma New Biological 72 SC Injection A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Biological in Healthy Subjects and Subjects with Moderate to Severe Psoriasis
Dermatology- Psoriasis
Healthy subjects
US Big Pharma New Biological 4 SC Injection A Long-term Assessment of the Safety and Efficacy of a New Biological Subcutaneous Treatment in Subjects with Psoriasis
Dermatology - Psoriasis
Patients
US Biotech Existing Chemical Entity
30 Topical A Phase I/II Pilot Single Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Two Topically Applied Gel Formulations in Patients with Postherpetic Neuralgia
Allodynic Pain Patients
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NUCLEUS NETWORK LIMITED Clinical Trials List
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EARLY PHASE STUDIES
Australian Biotech
Existing Chemical Entity
16 Oral A Comparative Pharmacokinetic Study of a Single Oral Dose of an Anti-depressant Compared with a Deuterated Analogue in Healthy Volunteers.
CNS - Depression Healthy subjects
Big Pharma New Chemical Entity
60 Oral Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral formulations in patients with Symptomatic Pulmonary Arterial Hypertension (PAH) Study
Cardiovascular- Respiratory
Patients
Big Pharma New Chemical Entity
60 Oral Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national, Study to Evaluate the Efficacy and Safety of oral formulations in patients with Chronic Thromboembolic Pulmonary Hypertension
Cardiovascular- Respiratory
Patients
Big Pharma New Chemical Entity
60 Oral Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national, Study to Evaluate the Efficacy and Safety of Oral Formulations in Patients with Symptomatic Pulmonary Arterial Hypertension
Cardiovascular- Respiratory
Patients
Big Pharma New Chemical Entity
60 Oral Long-term Extension, Multi-centre, Multi-national Study to Evaluate the Safety and Tolerability of Oral Formulations in Patients with Chronic Thromboembolic Pulmonary Hypertension
Cardiovascular- Respiratory
Patients
EU Big Pharma Existing Chemical Entity
20 Oral A Randomized,Double-Blind, 2-way Crossover, Placebo-Controlled Study to Investigate the Influence of a Single-Dose of Moxifloxacin on the QTc Interval in Healthy Male and Female Subjects for Positive Control Validation of a Parallel Patient Study
Pulmonary Arterial Hyprtension
Healthy subjects
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NUCLEUS NETWORK LIMITED Clinical Trials List
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EARLY PHASE STUDIES
Australian Biotech
New Chemical Entity
1 IV Infusion A Phase 1, Two-Stage, Dose-Escalation Study of a Novel Vascular Disrupting Agent in Patients with Advanced Solid Tumours
Oncology Patients
Australian Biotech
New Chemical Entity
72 Oral A Phase I, Single-Centre, Double-Blind, Placebo-Controlled, Escalating Single Oral Dose, Safety and Tolerability Clinical Trial with a New Chemical Entity in Healthy Subjects
Respiratory Syncytial Virus
Healthy subjects
Australian Biotech
New Chemical Entity
40 Oral Suspension A Phase I, Single-Centre, Placebo Controlled, Dose-Escalating Study of the Safety and Pharmacokinetics of a New Chemical Entity in Healthy Male Volunteers Administered Orally in the Fasted and Fed State
Hepatitis C Healthy subjects
EU Big Pharma New Chemical Entity
32 Oral Safety, Antiviral Effect and Pharmacokinetics of a New Chemical Entity inCombination with Another New Chemical Entity and with Ribavirin for 4 (Part 1) and with or without Ribavirin for 24-48 weeks (Part 2) in patients with Chronic HCV genotype 1 infection (randomized, open label, Phase II)
Hepatitis C Patients
US Big Pharma New Formulation
128 Oral Placebo-Controlled, Double-Blind, Ascending Single and Multiple Oral Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a New Formulation and to Assess Its Marker Specific Pharmacodynamics in Relation to Prednisolone in Healthy Males
Anti-Inflammatory Patients
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EARLY PHASE STUDIES
US Big Pharma Phase I (not FTIH)
24 Oral Suspension A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of a Compound in Healthy Subjects
Cardiovascular – Lipid lowering
Healthy subjects
US Big Pharma New Biological 5 Oral A Phase 1 Multiple Ascending Dose Study of a New Biological in Subjects with Advanced Metastatic Solid Tumours.
Oncology Patients
US Big Pharma New Chemical Entity
56 Oral Suspension Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of a New Chemical Entity in Healthy Subjects
Cardiovascular - Cholesterol reduction
Healthy subjects
US Big Pharma New Chemical Entity
104 Oral A placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Chemical Entity in Healthy Volunteers
Rheumatology Healthy subjects
US Big Pharma New Chemical Entity
40 Oral Suspension A Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a New Chemical Entity in Healthy Male Subjects.
Diabetes Healthy subjects
US Big Pharma Phase I (not FTIH)
40 Oral Suspension A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a Compound in Healthy Subjects
Cardiovascular – Lipid lowering
Healthy subjects
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EARLY PHASE STUDIES
US Big Pharma New Chemical Entity
56 Oral A Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Chemical Entity in Healthy Subjects
Oncology Healthy subjects
US Big Pharma New Chemical Entity
40 Oral Suspension Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a New Chemical Entity in Healthy Male Subjects.
Diabetes Healthy subjects
US Big Pharma New Biological 5 Oral Phase 1 Multiple Ascending Dose Study of a New Biological in Subjects with Advanced Metastatic Solid Tumours.
Oncology Patients
US Big Pharma Phase I (not FTIH)
40 Oral Suspension Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of an Oral Suspension in Healthy Subjects
Cardiovascular - cholesterol reducing
Healthy subjects
US Biotech New Transdermal Drug Delivery System
20 Transdermal A Phase 1 Study to Evaluate the Pharmacokinetics and Safety During Treatment with a 7-Day Patch, Delivery System (TDS), and Branded Capsules for 7 Days in Healthy Male Volunteers.
Urology Healthy subjects
US Biotech New Transdermal Drug Delivery System
16 Transdermal Phase 1 Study to Evaluate the Pharmacokinetics and Safety of a Hormone administered via a Transdermal Delivery System and Subcutaneous Injection in Healthy Female Volunteers
Rheumatology - Osteoporosis
Healthy subjects
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NUCLEUS NETWORK LIMITED Clinical Trials List
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EARLY PHASE STUDIES
Australian Biotech
New Chemical Entity
9 IV infusion A Prospective Single Arm, Two Stage, Open-Label, Phase II trial of a New Chemical Entity in Relapsed and Refractory Multiple Myeloma.
Oncology Patients
US Biotech New Chemical Entity
8 Oral A Phase 1b, Open Label Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Chemical Entity Administered Orally Twice a Day for 28 days Immediately Prior to Initiation of Treatment with HCV Standard of Care Therapy in Treatment-Naïve Subjects Chronically Infected with HCV.
Hepatitis C Patients
US Big Pharma New Biological 20 IV Infusion A Safety, Tolerability and Efficacy Study of an Intravenous Compound in Subjects with Rheumatoid Arthritis Receiving Background Oral DMARDs.
Rheumatoid Arthritis
Patients
US Big Pharma New Biological 72 SC Injection Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Biological After Multiple Subcutaneous Injections in Subjects with Type 2 Diabetes.
Asthma Healthy subjects
Australia Biotech
Existing Chemical Entity
24 Inhaled A Phase I, Clinical Trial to Determine the Pharmacokinetics of a Reproductive Hormone and Ethinyl Estradiol Following Transdermal Application with a Metered Dose Transdermal Applicator
Reproduction - Menopause
Healthy subjects
China Biotech New Chemical Entity
24 SC Injection A Phase 1, Open Labelled, Dose Escalation Trial in Healthy Subjects to Examine the Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose of a New Chemical Entity
Haematology Healthy subjects
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EARLY PHASE STUDIES
US Biotech/Pharma
Phase I (not FTIH)
36 Inhaled A Phase I, Randomised, Double-Blind, Placebo-Controlled Multiple Dose Trial to Assess the Safety, Tolerability, and Pharmacokinetics of an Inhalation Compound in Healthy Volunteers
Respiratory - Cystic Fibrosis
Healthy subjects
US Biotech/Pharma
New Chemical Entity
12 Inhaled A Phase I Randomised, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability and Pharmacokinetics of a New Chemical Entity in Subjects with Cystic Fibrosis (CF)
Respiratory- Cystic Fibrosis
Patients
US Biotech/Pharma
Phase I (not FTIH)
12 Inhaled A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Compound in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Respiratory - COPD Patients
US Biotech/Pharma
New Chemical Entity
12 Inhaled A Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety and Tolerability of a New Chemical Entity in Healthy Male Volunteers
Respiratory - Cystic Fibrosis
Healthy subjects
US Biotech/Pharma
New Chemical Entity
15 Inhaled A Phase 1 Randomised, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a chemical entity in Healthy Male Volunteers
Respiratory - Cystic Fibrosis
Healthy subjects
EU Big Pharma Phase I (not FTIH)
24 Oral A Phase I, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics , and Pharmacodynamics of Repeat Oral Doses of a new chemical entity in Healthy Subjects
Haematology - Anaemia
Healthy subjects
EU Big Pharma New Biological 36 IV Infusion A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety,
Neurology - Multiple Sclerosis
Patients
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EARLY PHASE STUDIES
Tolerability and Pharmacokinetics of a New Biological Administered by Intravenous (IV) Infusion to Patients with Relapsing Forms of Multiple Sclerosis, not on Disease Modifying Therapy
EU Big Pharma New Chemical Entity
42 Oral A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Food Effect of Single Oral Doses of an Inhibitor, in Healthy Subjects
Oncology Healthy subjects
EU Big Pharma New Biological 6 IV Infusion A Randomised, Single-blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Intravenous Infusion of a New Biologic in Patients with Alzheimer’s Disease
Neurology - Alzheimers Disease
Patients
EU Big Pharma New Chemical Entity
4 Intravenous A Randomized, Double-Blind, Placebo-Controlled, Bayesian Adaptive Dose Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Intravenous Infusions of a Chemical Entity in Patients with Active Rheumatoid Arthritis (RA).
Rheumatology Patients
EU Big Pharma Monoclonal Antibody
9 IV Infusion Clinical Phase I/IIA Study of Subcutaneous Administration of a Monoclonal Antibody in Rheumatoid Arthritis Patients on Stable Dose Methotrexate
Rheumatology Patients
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NUCLEUS NETWORK LIMITED Clinical Trials List
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EARLY PHASE STUDIES
EU Big Pharma New Biological 6 IV Infusion A Randomised, Single-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Intravenous Infusion of a New Biological in Patients with Alzheimer’s Disease
Neurology - Alzheimers Disease
Patients
EU Big Pharma FTIH 12 A Phase I, Open-Label Two-Stage Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Oral AKT Inhibitor in Subjects with Haematologic Malignancy
Oncology Patients
EU Big Pharma Phase I (not PTIH)
Oral A Phase I Open label Dose Escalation Study of an Inhibitor in Subjects with Solid Tumours
Oncology Patients
Australian Biotech
Existing Chemical Entity
15 Topical A Phase I/IIa Study to Determine the Safety, Tolerability and Absorption of a Lotion Administered Topically to the Hair and Scalp of Subjects with Head Lice
Anti-bacterial - Head Lice
Patients
China Biotech New Biological 40 Oral Suspension A Phase 1 Randomized, Double-Blinded ,Placebo Controlled Trial in Healthy Male Volunteers to Examine the Safety, Tolerability, and Pharmacokinetics of a New Biological After a Single Dose
Rheumatology Healthy subjects
China Biotech Phase I (not FTIH)
24 Oral A Phase 1, randomized, double-blind, placebo-controlled trial in healthy male volunteers to examine the safety, tolerability and pharmacokinetics of a compound after multiple dosing for 14 days
Rheumatology Healthy subjects
US Biotech New Biological 36 IV Infusion A Randomized, Double-Blind, Placebo-Controlled, MultiCenter Study of a new biological to Evaluate Safety,
Cardiovascular - CABG
Patients
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EARLY PHASE STUDIES
Pharmacokinetics and Proof-Of-Concept Efficacy for Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Participants Undergoing Coronary Artery Bypass Graft (CABG) Surgery
US Biotech New Chemical Entity
32 IV Infusion A Phase I, Randomised, Single-Blind, Placebo-Controlled, Single-Center, Dose Escalation Study of a Bolus Injection of a New Chemical Entity
Cardiovascular Healthy subjects
US Biotech New Chemical Entity
21 IV Infusion A Phase I, Single-Center, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Tolerability, Safety and Pharmacokinetics of a Single Intravenous Infusion of a New Chemical Entity Administered to Healthy Adult Male Volunteers
Asthma Healthy subjects
US Biotech New Chemical Entity
56 IV Infusion A Double-Blind, Randomized, Placebo Controlled, Rising Single Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of a New Chemical Entity in Healthy Male Volunteers
Renal Healthy subjects
US Biotech New Chemical Entity
16 IV Infusion A Double-Blind, Randomized, Placebo-Controlled, Two Period Crossover Study to Assess the Safety and Tolerability of Single Ascending Doses of a New Chemical Entity in Haemodialysis Subjects with Secondary Hyperparathyroidism
Renal Patients
US Biotech New Biological 12 SC Injection A Phase 1 Randomised Double-Blind, Placebo-Controlled, Single Dose, Dose Escalation Study of a rheumatology compound in Healthy Male Volunteers.
Rheumatology Healthy subjects
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EARLY PHASE STUDIES
US Biotech New Chemical Entity
62 Oral A Single Centre, Open-Label Phase 1 study to Investigate the Safety, Tolerability and Pharmacokinetcs of Five Sequential Single Doses Followed by Three Sequential Multiple Dose Regimens of a New Oral Chemical Entity in Healthy Male Subjects.
Transplantation Healthy subjects
US Biotech New Chemical Entity
40 Oral Suspension A Randomized, Double-Blind, Placebo-Controlled Phase 1 Studyto Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of a New Chemical Entity Given With or Without Tacrolimus in Healthy Male Subjects
Transplantation Healthy subjects
US Biotech New Chemical Entity
40 Oral Suspension A Single-Centre, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of a New Chemical Entity Given With or Without Tacrolimus in Healthy Male Subjects and Male Subjects with Metabolic Syndrome
Transplantation Healthy subjects
US Big Pharma New Vaccine 30 SC A Phase IIa Randomised Double-Blinded, Clinical Trial to Study the Tolerability and Immunogenicity of a Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Healthy 16-26 -Year –Old Women
Human Papilloma Virus
Healthy subjects
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EARLY PHASE STUDIES
New Zealand Biotech
New Formulation
40 IV Infusion A Phase 1, Double-Blind, Randomized, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of a New Formulation in Healthy Female Subjects, When Administered as Loading Dose(10-minute infusion), and as a Loading Dose Followed by a Maintanance Dose(72-hour infusion)
Neurology Healthy subjects
Australian Biotech
New Vaccine 18 SC Injection A Phase I Study to Determine Safety, Tolerability and Bioactivity of a New Vaccine in HLA DQ2+ Volunteers with Coeliac Disease Following a Long-term, Strict Gluten-free Diet
Coeliac disease Patients
US Big Pharma Existing Chemical Entity
24 Oral An Open-Label, Randomized, 2-way, Cross-Over Study, to Assess Potential Drug- Drug interactions in healthy adult subjects
Cardiovascular Healthy subjects
US Big Pharma New Biological ?? Intravenous A Phase 1, Randomised, Placebo-controlled, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Single Intravenous Dose of a New Biologic in Patients with Mild-to-Moderate Alzheimer's disease.
Alzheimer's Disease
Patients
US Big Pharma New Biological 5 IV Infusion A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Multiple Doses of a New Biological in Patients with Mild to Moderate Alzheimer's Disease.
Alzheimer's Disease
Patients
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EARLY PHASE STUDIES
US Biotech New Chemical Entity
39 IV Infusion A Phase 1, Open Label, Single-Center, Dose-Escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous (IV) Injection of a New Chemical Entity in Healthy Subjects
Anaesthesia Healthy subjects
US Biotech/Pharma
New Chemical Entity
80 Oral A Phase 1, Single-Centre, Dose-Escalation and Fixed-Dose Crossover, Cohort Study to Determine the Safety and Pharmacokinetics of a Single Oral Dose of a New Chemical Entity in Healthy Subjects
Pain Healthy subjects
EU Big Pharma New Chemical Entity
20 A Multicenter, Randomized, Pilot Phase 1 Study to Evaluate the Combination of an HCV Polymerase Inhibitor and HCV Protease Inhibitor in Genotype 1 Chronic Hepatitis C Patients
Hepatitis C Patients
EU Big Pharma New Biological 10 IV Infusion A Randomised Double-Blind, Multiple-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Biological following Intravenous Infusion in Healthy Volunteers and Patients with Peripheral Arterial Disease.
Vascular - Peripheral Arterial Disease
Patients
US Big Pharma New Chemical Entity
15 Oral Multicenter, Randomized, Pilot Phase 1 Study to Evaluate the Combination of a New Chemical Entity in Genotype 1 Chronic Hepatitis C Patients
Hepatitis C Patients
EU Big Pharma New Formulation
32 Oral Relative Bioavailability of Four Prototype Formulations in Comparison to the Reference Phase 1 Capsule Formulation, after Single Oral Administration under
Cardiovascular Healthy subjects
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EARLY PHASE STUDIES
Fasting and Fed Conditions to Healthy Male Subjects.
US Big Pharma Existing Chemical Entity
24 IV Infusion A Rising Single Dose and Multiple-Dose Tolerability, Safety and Pharmacokinetic Study of an Intravenous Compound in Healthy Volunteers and Patients with Psoriasis
Dermatology- Psoriasis
Healthy subjects
US Big Pharma New Formulation
32 SC Injection A Single Dose Safety and Tolerability Placebo Controlled Study of Subcutaneous New Formulation in Healthy Volunteers
Dermatology - Psoriasis
Healthy subjects
US Big Pharma New Chemical Entity
23 Oral A Study to Further Understand the Effects of a new chemical entity on Tissue Neutrophils
Respiratory - COPD Healthy subjects
US Big Pharma New Chemical Entity
24 SC Injection A Rising Single-dose and Multiple-dose Safety, Tolerability and Pharmacokinetic Study of a New Chemical Entity in Healthy Volunteers and Subjects with Rheumatoid Arthritis
Rheumatology Healthy subjects
EU Big Pharma New Formulation
36 Oral A Comparative Pharmacokinetic Study of Strontium after Single Oral Administration of Three Different Salts of a New Formulation. An Open Parallel Randomised Study Performed in 3 groups of 12 Young Healthy Male Volunteers
Postmenopausal osteoarthritis
Healthy subjects
EU Big Pharma Phase I (not FTIH)
16 Oral A Pilot Single Dose Study to Compare the In-Vivo Release Profiles from Three Fixed Combination Tablets, Varying by their In-Vitro Release Rates, with the Free Combination Formulation, and an Oral Solution. Single dose, Open-label, Modified Randomised (five-period) Four-way
Diabetes Healthy subjects
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EARLY PHASE STUDIES
Crossover Study in Healthy Male VolunteersEU Pharma New Chemical
Entity32 Oral A Phase I, Pharmacokinetic Trial, in Healthy Asian and
Caucasian Volunteers for Investigating the Pharmacokinetic Profiles of a New Chemical Entity for Malaria
Infectious Diseases - Anti-parasitic
Healthy subjects(Caucasian and Asian)
Australian Biotech
New Chemical Entity
36 Oral A Phase I, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Compound Following Single Ascending Oral Dosing of the New Compound in Healthy Volunteers Administered in the Fasted and Fed State
Pain Healthy subjects
Australia Biotech
New Chemical Entity
12 Vaginal Gel Assessment of Local Retention and Duration of Activity of a Gel Following Vaginal Application in Healthy Female Volunteers
Infectious Disease -HIV
Healthy subjects
Taiwanese Biotech
Herbal Medicine
60 Oral Evaluation of the Efficacy of a Chinese Herbal Medicine in the Treatment of Patients with Osteoarthritis of the Knee
Osteoarthritis Patients
US Biotech ???? ??? ??? A Randomised, Placebo-Controlled Trial of a chemical entity in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
Diabetes Patients
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EARLY PHASE STUDIES
Japan Big Pharma
Existing Chemical Entity
260 Oral A Randomized, Double-blind, Placebo- and Positive-controlled, Parallel Study to Evaluate the Effect of a compound on the QT/QTc Interval in Healthy Adult Male and Female Subjects
Endocrine - Diabetes
Healthy subjects
US Big Pharma New Biological 5 IV Infusion A Phase 3, Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel-Group Efficacy and Safety Trial of a New Chemical Entity in Subjects with Mild to Moderate Alzheimer Disease who are Apolipoprotein E ε4 Non-Carriers.
Neurology- Alzheimer's Disease
Patients
US Big Pharma New Biological 5 IV Infusion A Phase 3, Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel-Group Efficacy and Safety Trial of a New Biological in Subjects with Mild to Moderate Alzheimer Disease who are Apolipoprotein E ε4 Carriers.
Neurology - Alzheimer's Disease
Patients
US Big Pharma New Vaccine 80 IM A Phase I Trial Evaluating the Safety, Tolerability and Immunogenicity of 3 Ascending Dose Levels of a Staphylococcus Aureus Vaccine in Healthy Adults
Infectious Disease Healthy subjects
US Big Pharma New Biological 5 IV Infusion A Phase 3, Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel-Group Efficacy and Safety Trial of a New Biological in Subjects with Mild to Moderate Alzheimer Disease who are Apolipoprotein E ε4 Non-Carriers.
Neurology-Alzheimer's Disease
Patients
US Biotech New Chemical Entity
50 IV Infusion A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New
Obesity Patients
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EARLY PHASE STUDIES
Chemical Entity in Obese Volunteers
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EARLY PHASE STUDIES
ETHNIC STUDIES
Sponsor Compound Type
No of Subjects
Route of Administration
Study Description Therapeutic Area Type of Subjects
US Big Pharma New Chemical Entity
32 Oral Influence of Race/Ethnic Origin on the Pharmacokinetics of a new chemical entity
Neurology Healthy subjects
US Big Pharma New Chemical Entity
32 Oral Influence of Race/Ethnic Origin on the Pharmacokinetics of a New Chemical Entity
Respiratory - COPD Healthy Japanese, Chinese and Causasian Subjects
US Biotech Existing Chemical Entity
24 Oral A Single-Dose, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of an Oral Formulation in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
Multiple Sclerosis Healthy subjects
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