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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612506
• Other study ID #: L47-Ia-01
• Status: Completed
• Phase: Phase 1
• First received: September 16, 2015
• Last updated: February 13, 2017
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: Shanghai HEP Pharmaceatical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	302 Military Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai HEP Pharmaceatical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Plasma Concentration (Cmax)		half a year
Secondary	Area under the plasma concentration versus time curve (AUC)		half a year
Secondary	half-time		half a year
Secondary	apparent volume of distribution		half a year