NCT06159062

A Clinical Study of 162 in Subjects With Chronic Hepatitis B Virus Infection

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 162 With a Single Ascending Dose in Subjects With Chronic Hepatitis B Virus Infection

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Yangshengtang Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this intervention research is to learn about the safety and tolerability of 162 with a single ascending dose in subjects with chronic hepatitis B virus (HBV) infection.

Detailed description

This is a multi-center, randomized, double-blind and placebo-controlled dose escalation study design. The dose-escalation stage will be conducted sequentially at 3 dose cohorts, which are 50 mg in the pre-test, 75 mg and 100 mg in the formal test. Two subjects with chronic HBV infection will be enrolled in the 50 mg dose cohort and all will be given the investigational product 162. Four subjects with chronic HBV infection will be enrolled in the 75 mg and 100 mg dose cohorts, respectively. Subjects in each cohort will be randomized 3:1 to receive a single ascending dose of 162 or placebo.

Conditions

• Chronic Hepatitis B Virus Infection

Interventions

Type	Name	Description
DRUG	162	The investigational product 162 is a novel monoclonal antibody targeting HBsAg.
DRUG	Placebo	Placebo do not consist any active ingredients.

Timeline

• Start date: 2024-06-03
• Primary completion: 2024-07-09
• Completion: 2024-07-09
• First posted: 2023-12-06
• Last updated: 2024-07-16

Locations

1 site across 1 country: Australia