NUCLEUS NETWORK LIMITED
Clinical Trials List
FTIH Studies
www.nucleusnetwork.com.au
Sponsor
Compound
Type
No of
Subjects
Route of
Administration
Study Description
Therapeutic
Area (I)
Type of
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
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
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
DermatologyPsoriasis
Healthy
subjects
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
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
1|Page
NUCLEUS NETWORK LIMITED
Clinical Trials List
FTIH Studies
www.nucleusnetwork.com.au
Australian
Biotech
New Chemical
Entity
40
Oral Suspension
A Phase I, Single-Centre, Placebo Controlled, DoseEscalating 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
US Big Pharma
New
Formulation
128
Oral
Anti-Inflammatory
Patients
US Big Pharma
New
Biological
5
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
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
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
2|Page
NUCLEUS NETWORK LIMITED
Clinical Trials List
FTIH Studies
www.nucleusnetwork.com.au
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
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 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
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
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)
RespiratoryCystic Fibrosis
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
3|Page
NUCLEUS NETWORK LIMITED
Clinical Trials List
FTIH Studies
www.nucleusnetwork.com.au
EU Big Pharma
New
Biological
36
IV Infusion
A Randomised, Double-blind, Placebo-controlled, Single
Ascending Dose Study Exploring the Preliminary Safety,
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
Neurology Multiple Sclerosis
Patients
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 Biological in Patients with Alzheimer’s
Disease
Neurology Alzheimers
Disease
Patients
EU Big Pharma
FTIH
12
Oral
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
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
4|Page
NUCLEUS NETWORK LIMITED
Clinical Trials List
FTIH Studies
www.nucleusnetwork.com.au
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
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
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
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
5|Page
NUCLEUS NETWORK LIMITED
Clinical Trials List
FTIH Studies
www.nucleusnetwork.com.au
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 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
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
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
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
6|Page