Study of Hepalatide(L47) at Phase Ib in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Hepatitis B， Chronic
• Intervention / Treatment: Drug: Hepalatide; Drug: Placebo

Detailed Description

This is a randomized, double-blinded, dose escalating, phase Ib trial, which will be conducted in No. 302 Hospital of China. There are three cohorts at dose of 4.2mg, 6.3mg and 8.4mg. All healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, all healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be observed for 3 days.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • 302 Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hepalatide; Hepalatide 4.2mg, 6.3mg and 8.4mg	Drug: Hepalatide; There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.; Other Names: treatment drug
PLACEBO_COMPARATOR: Placebo; Placebo 4.2mg, 6.3mg and 8.4mg	Drug: Placebo; There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.; Other Names: control drug

What is the study measuring?

Primary Outcome Measures

Outcome 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	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax)	6 months
Area under the plasma concentration versus time curve (AUC)	6 months
half-time	6 months
apparent volume of distribution	6 months

Collaborators and Investigators

• Sponsor: Shanghai HEP Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (ESTIMATE): January 18, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: L47-Ib-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO