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

NCT05470829 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-07-22

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers
  • Hepatitis B, Chronic

Interventions

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

Sponsors & Collaborators

  • Shanghai Zhimeng Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Junqi Niu · The First Hospital of Jilin University

  • Yanhua Ding · The First Hospital of Jilin University

  • Hongxin Piao · Yanbian University Affiliated Hospital (Yanbian Hospital)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2021-11-17
Completion
2021-11-17
FDA Drug
Yes

Countries

  • China

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 NCT05470829 on ClinicalTrials.gov