Not Yet RecruitingPhase 1ACTRN12612000713897

A study to evaluate the safety, tolerability, and pharmacokinetics of a single dose of the drug F-652 in healthy male volunteers.

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.

Sponsor

Generon Corporation Ltd

Enrollment

40 participants

Start Date

Aug 31, 2012

Study Type

Interventional

Conditions

Alcoholic Hepatitis

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.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria5

No clinically signifcant findings in medical history and physical examination, especially normal hepatic and renal function.
BMI >19 and < 30mg/m2
No clinically significant laboratory values and urinalysis
Normal Quantiferon test, ECG, blood pressure and heart rate
Aged between 18 and 45 years

Exclusion Criteria6

Family history of premature Coronary Heart Disease (CHD)
Any condition requiring regular use of medication
Exposure to prescription medication or to drugs known to interfere with metabolism of drugs within 14 days prior to screening.
Current or history of malignancy disease
Haemorrhoids or anal disease with regular or recent presence of blood in faeces.
Presence or sequelae of hepatics and renal disease, or other medical conditions known to intefere with the absorption, distribution, metabolism and excretion of drugs

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Interventions

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.

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.