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

NCT05310487 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Yangshengtang Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-10-03
Completion
2023-10-22

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05310487 on ClinicalTrials.gov