NCT03971916

A Phase I Study Evaluating the Safety, Tolerability, PK and PD in Healthy Chinese Volunteers

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of HBM9161(HL161BKN) in Healthy Chinese Volunteers (Randomized, Single-blinded, Placebo-controlled Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Trial Objective: To investigate the safety, tolerability, PK, and PD following single ascending doses of HBM9161 in healthy Chinese subjects.

Detailed description

HBM9161(HL161BKN) is a human monoclonal antibody. HBM9161 targets the neonatal Fc receptor (FcRn) . The neonatal FcRn is a potential therapeutic target for many autoimmune diseases. This Phase I study will evaluate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of HBM9161(HL161BKN) (abbreviated as HBM9161) in healthy Chinese subjects. Up to 24 healthy Chinese subjects will be randomized into the study. For each dose group, 8 subjects will be randomized (6 subjects to HBM9161 group and 2 subjects to placebo group). This study will also provide guidance on doses to be used in future studies involving patients with autoimmune diseases.

Conditions

• Healthy Chinese Volunteers

Interventions

Type	Name	Description
DRUG	HBM9161(HL161BKN)	Subcutaneous injection; Single dose on Day 1
DRUG	Placebo	Subcutaneous injection; Single dose on Day 1

Timeline

• Start date: 2019-06-03
• Primary completion: 2019-11-06
• Completion: 2019-11-06
• First posted: 2019-06-03
• Last updated: 2021-03-10

Locations

1 site across 1 country: China