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Trial registered on ANZCTR


Registration number
ACTRN12612000713897
Ethics application status
Not yet submitted
Date submitted
3/07/2012
Date registered
3/07/2012
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the safety, tolerability, and pharmacokinetics of a single dose of the drug F-652 in healthy male volunteers.
Scientific title
Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of F-652 with a Single Dose in Healthy Male Volunteers.
Secondary ID [1] 280764 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcoholic Hepatitis 286820 0
Condition category
Condition code
Inflammatory and Immune System 287132 287132 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 287143 287143 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be administered with a single dose of either placebo or with F-652 (The Investigational Drug). Dose levels of F-652 will range from 2.0, 8.0, 30.0, 120.0 and 250.0 microgram/kg. Both F-652 or placebo will be administered via subcutaneous injection. As this is a dose escalation study, the first cohort of 8 participants will received the lowest dosage. Safety evaluation will then be performed based on the adverse event reported as well as from the safety laboratory results prior to dose escalating to the higher dose. The same process will be perform prior to every dose escalation. There will be 5 cohorts with 8 participants in each cohort for this study.
Intervention code [1] 285190 0
Treatment: Drugs
Comparator / control treatment
Placebo consisting of Saline Solution 9% will be administered
Control group
Placebo

Outcomes
Primary outcome [1] 287453 0
Adverse events post investigational drug administration. Adverse events are defined as any changes observed relative to baseline observation (screening) and include but not limited to the following:
1. Changes in physical appearance e.g. bruising, bloodshot eyes, etc.
2. Significant changes blood parameters
3. Changes in general well being e.g. headache, fatigue, etc
Timepoint [1] 287453 0
From enrolment into the study (Screening) until the end of the study on Day 22 post drug administration.
Secondary outcome [1] 298186 0
Levels of F-652 (Investigational Drug) in serum samples
Timepoint [1] 298186 0
Pharmacokinetics samples will be taken at Pre-dose, 1, 2, 4 8, 16, 24, 36 hours and 3, 4, 5, 6, 8, 11, 15, 22 days after investigational drug administration

Eligibility
Key inclusion criteria
1.No clinically signifcant findings in medical history and physical examination, especially normal hepatic and renal function.

2. BMI >19 and < 30mg/m2

3. No clinically significant laboratory values and urinalysis

4. Normal Quantiferon test, ECG, blood pressure and heart rate

5. Aged between 18 and 45 years
Minimum age
18 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Family history of premature Coronary Heart Disease (CHD)

2. Any condition requiring regular use of medication

3. Exposure to prescription medication or to drugs known to interfere with metabolism of drugs within 14 days prior to screening.

4. Current or history of malignancy disease

5. Haemorrhoids or anal disease with regular or recent presence of blood in faeces.

6. Presence or sequelae of hepatics and renal disease, or other medical conditions known to intefere with the absorption, distribution, metabolism and excretion of drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285551 0
Commercial sector/Industry
Name [1] 285551 0
Generon Corporation Ltd
Address [1] 285551 0
Suite 302/303, Building 9, 1011 Ha Lei Road Z.J. Hi-Tech Park Shanghai 201203, P.R. China
Country [1] 285551 0
China
Primary sponsor type
Commercial sector/Industry
Name
Generon Corporation Ltd
Address
Suite 302/303, Building 9, 1011 Ha Lei Road Z.J. Hi-Tech Park Shanghai 201203, P.R. China
Country
China
Secondary sponsor category [1] 284391 0
Commercial sector/Industry
Name [1] 284391 0
Nucleus Network Ltd
Address [1] 284391 0
Lvel 5, Burnet Building, 89 Commercial Road, Melbourne 3004 Victoria
Country [1] 284391 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287569 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 287569 0
Alfred Hospital, 55 Commercial Road, Melbourne 3004, VIC
Ethics committee country [1] 287569 0
Australia
Date submitted for ethics approval [1] 287569 0
25/06/2012
Approval date [1] 287569 0
Ethics approval number [1] 287569 0
1/12/0283

Summary
Brief summary
F-652 is intended for the treatment for Alcoholic Hepatitis which results in the inflammation of the liver. This is a single dose escalation study testing evaluating dose levels of 2.0, 8.0, 30.0, 120.0 and 250.0 microgram/kg. This is the first time F-652 is tested in humans and that is to establish safety and tolerability, to evaluate how the body handles the drug (pharmacokinetics) and what the drug does to the body (pharmacokinetics) compared to when the drug was tested in animal models.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34382 0
Address 34382 0
Country 34382 0
Phone 34382 0
Fax 34382 0
Email 34382 0
Contact person for public queries
Name 17629 0
Jeffery Wong
Address 17629 0
Level 5, Burnet Building, 89 Commercial Road, Melbourne 3004, Victoria
Country 17629 0
Australia
Phone 17629 0
+613 9496 6729
Fax 17629 0
+613 9076 8911
Email 17629 0
j.wong@nucleusnetwork.com.au
Contact person for scientific queries
Name 8557 0
Jeffery Wong
Address 8557 0
Level 5, Burnet Building, 89 Commercial Road, Melbourne 3004, Victoria
Country 8557 0
Australia
Phone 8557 0
+613 9496 6729
Fax 8557 0
+613 9076 8911
Email 8557 0
j.wong@nucleusnetwork.com.au

No information has been provided regarding IPD availability
Summary results
No Results