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

NCT06905847 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-04-02

No results posted yet for this study

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

DRUG

HSK39004 in healthy

1.5-12mg

DRUG

HSK39004

Placebo

DRUG

HSK39004 in COPD

1.5-6mg

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2025-01-13
Completion
2025-03-20

Countries

  • China

Study Locations

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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 NCT06905847 on ClinicalTrials.gov