Phase 1 Study of HRS-9821 Powder Inhalation to Test Safety and Effects in Healthy Adults and COPD Patients

What this Trial Is About

Researchers are evaluating the safety and tolerability of HRS-9821 Powder for Inhalation when given as a single dose to healthy adults and as multiple doses to patients with chronic obstructive pulmonary disease COPD. This Phase I study seeks to understand how the drug behaves in the body and its effects on patients with COPD compared to healthy participants. Participants are randomly assigned to inhale either HRS-9821 powder or a placebo. Healthy participants receive a single dose, while patients with COPD receive the inhaled powder or placebo daily for 12 days. The study uses a quadruple masking design to prevent bias and includes parallel groups to compare responses. The treatment period lasts up to 12 days depending on the group. During the study, participants undergo regular monitoring including assessments of adverse events, plasma drug levels, and vital signs. Screening includes pulmonary function tests and chest X-rays for COPD patients. Researchers collect safety data up to 26 days after dosing. Participants follow strict contraception rules and proper use of inhalation devices is checked to ensure adherence. The total study duration varies by participant group and includes follow-up periods for safety evaluation.

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