Phase I Study of Safety and Effects of HRS-9821 Inhalation Powder and Suspension in Healthy Adults and Patients With COPD

What this Trial Is About

Researchers are studying the safety and tolerability of HRS-9821 Powder for Inhalation and inhalation suspension in both healthy adults and patients with COPD. This Phase I trial aims to assess how these treatments are tolerated when given as a single dose in healthy individuals and multiple doses in people with COPD. The study also evaluates how the drug behaves in the body and its effects on heart rate, QT interval, and lung drug concentrations. Participants receive either HRS-9821 powder or inhalation suspension, or matching placebos, by inhalation. Healthy subjects receive a single dose, while patients with COPD are treated for 12 consecutive days. Another group receives oral moxifloxacin as an active comparator. The trial is randomized and includes four groups, with both experimental and placebo arms. During the study, participants undergo various assessments including heart monitoring, lung function tests, blood sampling to measure drug levels, and chest X-rays. The research team tracks adverse events up to 40 days after dosing to evaluate safety. Healthy subjects are monitored for up to 29 days after the single dose. The trial spans from screening through post-treatment observation, with detailed follow-up to understand the drugs effects and tolerability.

A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation and Inhalation Suspension Administered in Healthy Subjects and Multiple Doses in Patients With COPD.