NCT05790694

A Trial of HBM9378 in Healthy Chinese Subjects

A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I Clinical Study in Healthy Chinese Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of HBM9378 (SKB378) After Subcutaneous Administration.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective is to evaluate the safety, tolerability and pharmacokinetic profile of a single subcutaneous injection of HBM9378 (SKB378) at different doses in healthy Chinese subjects.

Detailed description

The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive HBM9378 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	HBM9378 (SKB378) Injection	Strength: 225 mg (1.5 mL)/vial
DRUG	Placebo	Strength: 225 mg (1.5 mL)/vial

Timeline

• Start date: 2022-08-26
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2023-03-30
• Last updated: 2023-03-30

Locations

1 site across 1 country: China