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COMPLETED
NCT06746311
PHASE1

This is a Phase 1 Study in Which Healthy Volunteers and Participants With Chronic HBV Infection Will be Assessed for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity

Sponsor: Suzhou HepaThera Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

Phase 1 Study of HT-101 in Healthy Subjects and Patients With Chronic Hepatitis B The trial consisted of two components. Part A involved a single ascending dose study where healthy participants were administered one dose of HT-101 or placebo subcutaneously (SC). Part B involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered two dose of HT-101 or placebo every 4 weeks subcutaneously (SC).

Official title: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-101 Injection in Healthy Subjects and Patients With Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Doses, and Dose Escalation Phase 1 Clinical Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2022-11-22

Completion Date

2024-06-17

Last Updated

2026-11-02

Healthy Volunteers

Yes

Interventions

DRUG

HT-101

Single dose of HT-101 administered subcutaneously.

DRUG

HT-101

Multiple dose of HT-101 administered subcutaneously.

DRUG

Placebo

Placebo, containing no active ingredient, administered subcutaneouly

Locations (7)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Nanfang Hospital

Guangzhou, Guangdong, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Yanbian University Hospital

Yanji, Jilin, China

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China