NCT07095855View on ClinicalTrials.gov

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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,300

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2030

Conditions
Chronic Hepatitis B
Interventions
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.

OTHER

ZM-H1505R Placebo

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

COMBINATION_PRODUCT

"NAs （EntecavirorTenofovirorTenofovir alafenamideorTMF） treatments"

"All eligible subjects will be use NAs （EntecavirorTenofovirorTenofovir alafenamideorTMF） 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."

Trial Locations (1)

130000

The First Hospital of Jilin University, Changchun

All Listed Sponsors
lead

Shanghai Zhimeng Biopharma, Inc.

INDUSTRY