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

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

February 17, 2020

Primary Completion Date

November 18, 2020

Study Completion Date

November 18, 2020

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.

Trial Locations (1)

07094

Frontage Clinical Services, Secaucus

All Listed Sponsors
lead

Shanghai Zhimeng Biopharma, Inc.

INDUSTRY

NCT04220801 - A Study of Orally Administered ZM-H1505R to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Doses in Healthy Participants | Biotech Hunter | Biotech Hunter