None listed
Conditions
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.
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. 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 pr
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.
Sponsors
Generon Corporation Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed