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

February 13, 2017 updated by: Shanghai HEP Pharmaceutical Co., Ltd.

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

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • 302 Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hepalatide
Hepalatide 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg
Drug: Hepalatide
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.
Other Names:
  • treatment drug
Placebo Comparator: Placebo
Placebo 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg
Drug: Placebo
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.
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
Time Frame: half a year
half a year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai HEP Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L47-Ia-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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