Hepatitis B， Chronic
Conditions
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.
Interventions
DRUGHepalatide
There are seven cohorts as follows 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. Dose of 0.21mg is a pilot trial with no placebo. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
DRUGPlacebo
There are six cohorts as follows 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
Sponsors
Shanghai HEP Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| half-time | half a year |
| apparent volume of distribution | half a year |
| Maximum Plasma Concentration (Cmax) | half a year |
| Area under the plasma concentration versus time curve (AUC) | half a year |
Countries
China
Outcome results
None listed