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A Study of Orally Administered ZM-H1505R to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Doses in Healthy Participants

NCT04220801 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-04-28

No results posted yet for this study

Summary

ZM-H1505R is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.

The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also test how the study drug is taken up and eliminated by the body. An additional part of the study is to look at how this could be changed by giving the study drug with food.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ZM-H1505R

Single oral doses of 300, 450, 600, 750, and 900 mg of ZM-H1505R or placebo and multiple oral doses of 450, 600, and 750 mg of ZM-H1505R or placebo will be administered in a fasted state, or in the case of Cohort 3 (Part 1), a second dose of 600 mg will be administered in the fed state. During each SAD and MAD dosing period, 2 subjects in each cohort will receive placebo instead of ZM-H1505R. The dose levels may be adjusted based on the safety and tolerability obtained from the previous cohort.

Sponsors & Collaborators

  • Shanghai Zhimeng Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory Tracey, MD. · Frontage Clinical Services, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2020-11-18
Completion
2020-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04220801 on ClinicalTrials.gov