A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT07640451
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • HRS-9821 Inhalation Suspension — DRUG
    HRS-9821 Inhalation Suspension.
  • HRS-9821 Placebo Inhalation Suspension — DRUG
    HRS-9821 Placebo Inhalation Suspension.

Study Details

The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.

Key Dates

First listed
Jun 10, 2026
Start date
Jul 20, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HRS-9821 Group - Dose 1
    HRS-9821 Inhalation Suspension, Dose 1.
  • Experimental: HRS-9821 Group - Dose 2
    HRS-9821 Inhalation Suspension, Dose 2.
  • Placebo Comparator: HRS-9821 Placebo Group - Dose 1
    HRS-9821 Placebo Inhalation Suspension, Dose 1.
  • Placebo Comparator: HRS-9821 Placebo Group - Dose 2
    HRS-9821 Placebo Inhalation Suspension, Dose 2.

Primary Outcome Measure

Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment. [ Time Frame: From baseline to 28 days after treatment. ]

Central Contacts

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