Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers

Conditions
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Hepatitis B， Chronic

Intervention / Treatment
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* Drug: Hepalatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepalatide<br>Hepalatide 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg | Drug: Hepalatide<br>* 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.<br>* Other names: treatment drug;|
| Placebo Comparator: Placebo<br>Placebo 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg | Drug: Placebo<br>* 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.<br>* Other names: control drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |