RecruitingPhase 1NCT07116915

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.


Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Enrollment

160 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I safety study testing a new inhaled drug called HRS-9821 in healthy adults and in people with chronic obstructive pulmonary disease (COPD). It evaluates how safe the drug is, how it is absorbed by the body, and what effects it has. **You may be eligible if...** - You are a healthy non-smoker aged 18–50 (for the healthy volunteer portion), OR - You are a man or woman aged 40–75 with a confirmed COPD diagnosis, and have smoked for at least 10 pack-years - You have a BMI of 18–33 kg/m² - Your ECG (heart tracing) is normal or not clinically significant **You may NOT be eligible if...** - You have a prolonged QTcF interval on ECG (≥450 ms) - You recently donated blood or had significant blood loss (within 4 weeks) - You are a healthy volunteer who currently smokes or quit smoking less than 12 months ago - You are unable to use the inhalation device correctly Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHRS-9821 Powder for Inhalation/HRS-9821 inhalation suspension

HRS-9821 Powder for Inhalation. HRS-9821 inhalation suspension

DRUGHRS-9821 Powder for Inhalation placebo/HRS-9821 inhalation suspension placebo

HRS-9821 Powder for Inhalation placebo. HRS-9821 inhalation suspension placebo

DRUGMoxifloxacin Hydrochloride Tablets

Moxifloxacin Hydrochloride Tablets


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07116915


Related Trials