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

Shanghai HEP Pharmaceutical Co., Ltd.48 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hepatitis B， Chronic

Interventions

HepalatideDRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

302 Military Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: half a year

Secondary Outcomes

Maximum Plasma Concentration (Cmax)

Time frame: half a year

Area under the plasma concentration versus time curve (AUC)

Time frame: half a year

half-time

Time frame: half a year

apparent volume of distribution

Time frame: half a year

Data from ClinicalTrials.gov

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