NCT06905847

Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Efficacy of HSK39004 Suspension for Inhalation

Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Characteristics of HSK39004 Suspension for Inhalation.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy of HSK39004 suspension for inhalation in multiple administrations in patients with Chronic Obstructive Pulmonary Disease（COPD）.

Conditions

• Healthy Donors

Interventions

Type	Name	Description
DRUG	HSK39004 in healthy	1.5-12mg
DRUG	HSK39004	Placebo
DRUG	HSK39004 in COPD	1.5-6mg

Timeline

• Start date: 2024-09-02
• Primary completion: 2025-01-13
• Completion: 2025-03-20
• First posted: 2025-04-02
• Last updated: 2025-04-02

Locations

1 site across 1 country: China