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

NCT03023787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-01-23

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 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.

DRUG

Placebo

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.

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
2016-08-31
Primary Completion
2016-12-31
Completion
2016-12-31

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 NCT03023787 on ClinicalTrials.gov