NCT05470829

A Multiple-dose Study in Chinese Subjects to Evaluate Safety,Tolerability,PK and PD of ZM-H1505R

A Multiple-center,Randomized,Double-blind,Placebo-controlled,Multiple-dose Study Among Chinese Healthy Subjects and Chronic Hepatitis B Patients to Evaluate Safety,Tolerability,Pharmacokinetics and Preliminary Pharmacodynamics of ZM-H1505R

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Shanghai Zhimeng Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This phase Ib study included two parts in which Part I was to evaluate the safety and bridge for PK among healthy Chinese subjects and Part II were about study among Chinese chronic hepatitis B virus-infected patients. Study of Part II was carried out following the safety assessment and racial difference evaluation in Part I.

Detailed description

This is a randomized, double-blind, placebo-controlled, multiple-dose phase Ib study. It aimed in this study to evaluate the safety and tolerability and to characterize the pharmacokinetics of ZM-H1505R among Chinese healthy subjects following single and multiple doses administration, and to assess whether there are ethnic differences in PK characteristic among Chinese and American healthy subjects. Study was also conducted to evaluate the safety and tolerability, to characterize the pharmacokinetics and to assess the preliminary pharmacodynamics of ZM-H1505R following multiple ascending dose administration among chronic hepatitis B virus-infected patients; the PK/PD model was established among adults to provide a basis for the oral doses determination in subsequent clinical studies of ZM-H1505R. Part I: Study among healthy subjects for safety evaluation and PK bridging Based on the PK results among American healthy subjects in Phase Ia study, 75 mg (cohort 1) was selected for PK bridging. Twelve healthy subjects were enrolled, of which 8 subjects received ZM-H1505R and 4 subjects received placebo. Part II: Study among chronic hepatitis B virus-infected patients Subjects in four cohorts (scheduled as cohort 2, 50 mg; cohort 3, 100 mg; cohort 4, 200 mg; cohort 5, 300 mg) were enrolled in sequence from 50 mg dose group (cohort 2). Dose ascending was continued when safety evaluation on Day 8 showed that the lower dose could be tolerated. Based on the results of PK and tolerability and PD, dose ascending to 300 mg dose group (cohort 5) from 200 mg dose group (cohort 4) was discontinued determined by sponsor and investigators. Ten chronic hepatitis B virus-infected patients were enrolled in each cohort to receive ZM-H1505R (n=8) or placebo (n=2).

Conditions

• Healthy Volunteers
• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	ZM-H1505R	Part 1 dosage form:75mg dosage:Tablet frequency: Quaque die duration: Day1; Day 4\~ Day 14 Cohort 1 of Part 2 dosage form:50mg dosage:Tablet frequency: Quaque die duration: Day 1\~ Day 28 Cohort 2 of Part 2 dosage form:100mg dosage:Tablet frequency: Quaque die duration: Day 1\~ Day 28 Cohort 3 of Part 2 dosage form:200mg dosage:Tablet frequency: Quaque die duration: Day 1\~ Day 28
OTHER	ZM-H1505R Placebo	Part 1 dosage form:75mg dosage:Tablet frequency: Quaque die duration: Day1; Day 4\~ Day 14 Cohort 1 of Part 2 dosage form:50mg dosage:Tablet frequency: Quaque die duration: Day 1\~ Day 28 Cohort 2 of Part 2 dosage form:100mg dosage:Tablet frequency: Quaque die duration: Day 1\~ Day 28 Cohort 3 of Part 2 dosage form:200mg dosage:Tablet frequency: Quaque die duration: Day 1\~ Day 28

Timeline

• Start date: 2021-05-27
• Primary completion: 2021-11-17
• Completion: 2021-11-17
• First posted: 2022-07-22
• Last updated: 2022-07-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study