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

Primary Purpose

Hepatitis B， Chronic

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Hepalatide
Placebo
Sponsored by
Shanghai HEP Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B， Chronic

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 302 Military Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hepalatide

Placebo

Arm Description

Hepalatide 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg

Placebo 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)
half-time
apparent volume of distribution

Full Information

First Posted
September 16, 2015
Last Updated
February 13, 2017
Sponsor
Shanghai HEP Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02612506
Brief Title
Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers
Official Title
A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai HEP Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B， Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hepalatide
Arm Type
Experimental
Arm Description
Hepalatide 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg
Intervention Type
Drug
Intervention Name(s)
Hepalatide
Other Intervention Name(s)
treatment drug
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
control drug
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Time Frame
half a year
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
half a year
Title
half-time
Time Frame
half a year
Title
apparent volume of distribution
Time Frame
half a year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhenman Wei
Organizational Affiliation
302 Military Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
302 Military Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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