search
Back to results

Study of Hepalatide(L47) at Phase Ib 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 4.2mg, 6.3mg and 8.4mg

Placebo 4.2mg, 6.3mg and 8.4mg

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
January 15, 2017
Last Updated
January 20, 2017
Sponsor
Shanghai HEP Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03023787
Brief Title
Study of Hepalatide(L47) at Phase Ib 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
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

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 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.

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
35 (Actual)

8. Arms, Groups, and Interventions

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

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
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs