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

NCT02612506 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-02-14

No results posted yet for this study

Summary

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

Conditions

  • Hepatitis B， Chronic

Interventions

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.

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.

Sponsors & Collaborators

  • Shanghai HEP Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • zhenman Wei · 302 Military Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02612506 on ClinicalTrials.gov