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COMPLETED
NCT06744686
PHASE1

Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients With Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity

Sponsor: Suzhou HepaThera Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study

Official title: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients With Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2023-06-12

Completion Date

2024-06-18

Last Updated

2026-11-02

Healthy Volunteers

Yes

Interventions

DRUG

HT-102

50mg, 150mg, 300mg, 600mg

DRUG

HT-102

50mg, 150mg, 300mg

DRUG

Placebo

Placebo

Locations (7)

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

People's Hospital of Qingyuan

Qingyuan, Guangdong, China

Luoyang Central Hospital

Luoyang, Henan, China

The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Shandong Public Health Clinical Center

Jinan, Shandong, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China