MedTrace Logo

A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB

NCT07095855 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2025-08-03

No results posted yet for this study

Summary

This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU/mL and are HBeAg positive who have received NAs monotherapy for at least 12months.Part B is an open-label extension and follow-up period designed to evaluate the long-term safety and efficacy of ZM-H1505R in combination with NAs.

Conditions

Interventions

OTHER

ZM-H1505R Placebo

ZM-H1505R Placebo(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks.

DRUG

ZM-H1505R 100mg

ZM-H1505R(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks and Part B open-label extension period 144 weeks.

COMBINATION_PRODUCT

NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments

All eligible subjects will be use NAs （"Entecavir"or"Tenofovir"or"Tenofovir alafenamide"or"TMF"） treatments during the study for 148 weeks, including Part A and Part B. Subjects will continue to use the NAs as combination therapy before enrollment, the dosage will not be adjusted during the study. Subjects use in accordance with medical advice andinstructions.

Sponsors & Collaborators

  • Shanghai Zhimeng Biopharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2028-01-31
Completion
2030-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07095855 on ClinicalTrials.gov