Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers
- Registration Number
- NCT02612506
- Lead Sponsor
- Shanghai HEP Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.
- Detailed Description
This is a randomized, double-blinded, dose escalating, phase Ia trial, which will be conducted in No. 302 Hospital of China. There are seven cohorts at dose of 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. The first cohort with 0.21mg is an open test with no placebo as control. All other healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, and will be received drug by abdominal subcutaneous injection and will be observed for 8 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Ages between 18 and 45 years
- BMI Index between 19 and 25 (BMI=weight/height2)
- Normal previous history and physical exam
- No drug and alcohol abuse
- No illness in 4 weeks and no drug therapy in 2 weeks
- No blood donation or subject not sampled in 3 months
- Consistent and correct use of recommended methods of birth control for men and women
- Good compliance with study protocol
- Understand and agree to sign a consent form
Exclusion Criteria
- Infection with HAV, HBV, HCV, HEV, HIV, EBV or CMV
- Abnormal and clinical significance test of physical examination, vital signs, blood routines, urine routines, liver and kidney functions, coagulation indicator, electrolyte, glucose, blood lipid, thyroid functions, chest X-Ray, ECG, B ultrasound of gallbladder, spleen and kidney, AFP ,and CEA
- Positive for anti-Pre-S1 antibody
- Women being pregnant or nursing, or with abnormal sex hormones, B ultrasound of ovaries/uterus proliferative diseases or breast mass
- Unable to quit smoking in trial
- Subject with little chance of enrollment (i.e. the weak)
- Subject not suitable to join the trial under other circumstances judged by investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg Hepalatide Hepalatide Hepalatide 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg
- Primary Outcome Measures
Name Time Method Healthy participants with treatment-related adverse events as assessed by "guiding principle of grading standards for the adverse reactions in clinical trials of vaccine for prevention" or CTCAE v4.0 half a year
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) half a year Area under the plasma concentration versus time curve (AUC) half a year half-time half a year apparent volume of distribution half a year
Trial Locations
- Locations (1)
302 Military Hospital
🇨🇳Beijing, Beijing, China