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

Sponsor
Shanghai HEP Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02612506
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
10
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Maximum Plasma Concentration (Cmax) [half a year]

    2. Area under the plasma concentration versus time curve (AUC) [half a year]

    3. half-time [half a year]

    4. apparent volume of distribution [half a year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 302 Military Hospital Beijing Beijing China 100039

    Sponsors and Collaborators

    • Shanghai HEP Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: zhenman Wei, 302 Military Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai HEP Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02612506
    Other Study ID Numbers:
    • L47-Ia-01
    First Posted:
    Nov 23, 2015
    Last Update Posted:
    Feb 14, 2017
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hepatitis B
    Hepatitis B, Chronic

    Study Results

    No Results Posted as of Feb 14, 2017