NCT05310487

Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics of 162 With a Single Ascending Dose in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Yangshengtang Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is the first in human study of 162, and the primary objective is to evaluate the safety and tolerability of 162 with a single ascending dose in healthy adult subjects. The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg in the pre-test, and 200 mg, 400 mg, 800 mg and 1200 mg in the formal test. Two healthy adult subjects will be enrolled at 100 mg dose level and all given 162. Eight healthy adult subjects will be enrolled at each remaining dose levels (200 mg, 400 mg, 800 mg and 1200 mg), respectively.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	162	The investigational product 162 is a novel neutralizing antibody targeting HBsAg, for the treatment of patients with chronic hepatitis B
OTHER	Placebo	an intervention that appearance is the same as 162, but contains no active ingredients

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-10-03
• Completion: 2023-10-22
• First posted: 2022-04-05
• Last updated: 2023-11-27

Locations

1 site across 1 country: Australia