A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPD

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT07567872
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • HRS-9821 Powder for Inhalation — DRUG
    HRS-9821 Powder for Inhalation
  • Placebo — DRUG
    placebo for HRS-9821 Powder Inhalation

Study Details

The aim of this study was to evaluate the safety and tolerability of HRS-9821 Powder for Inhalation administered in a single dose in healthy individuals and multiple doses in patients with COPD。

Key Dates

First listed
May 5, 2026
Start date
Jul 9, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: HRS-9821 Powder for Inhalation
    Participants inhaled HRS-9821 powder either as a single dose or for 12 days.
  • Placebo Comparator: placebo for HRS-9821 Powder Inhalation
    Participants received a single dose or 12 consecutive days of placebo for HRS-9821 Powder Inhalation with HRS-9821.

Primary Outcome Measure

Change from baseline in the rate of adverse events [ Time Frame: The screening period lasted until 26days after administration ]

Central Contacts

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