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

NCT02612506 | Completed Phase 1

• 1 other identifier: L47-Ia-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis B， Chronic

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• Maximum Plasma Concentration (Cmax)

  half a year

• Area under the plasma concentration versus time curve (AUC)

  half a year

• half-time

  half a year

• apparent volume of distribution

  half a year

Study Arms (2)

Hepalatide

EXPERIMENTAL

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

Drug: Hepalatide

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Hepalatide DRUG

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.

Also known as: treatment drug

Hepalatide

Placebo DRUG

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.

Also known as: control drug

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai HEP Pharmaceutical Co., Ltd.: lead

Study Sites (1)

302 Military Hospital

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Drug and Narcotic Control

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Legislation, Drug; Legislation as Topic; Social Control, Formal; Health Care Economics and Organizations; Pharmacy Administration; Organization and Administration; Health Services Administration

Study Officials

• zhenman Wei

  302 Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: November 23, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)