Actively Recruiting
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.
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2026-02-27
160
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent to participate
- Body weight at least 45 kg and BMI between 18 and 33 kg/m2
- Normal or clinically insignificant 12-lead ECG
- Use of effective contraception from consent until 1 month after last dose (HRS-9821/placebo) or 3 months after last dose (moxifloxacin in males)
- Proper use of inhalation devices and adherence to study procedures
- For healthy subjects: normal vital signs and pulmonary function, no smoking or smoking cessation for at least 12 months, smoking history less than 5 pack-years, male aged 18-50 years
- For COPD patients: male or female aged 40-75 years, diagnosed with COPD, post-bronchodilator FEV1/FVC ratio less than 0.7, FEV1 between 40% and 80% of predicted, smoking history of at least 10 pack-years, normal chest X-ray, willing to discontinue COPD medications before randomization
You will not qualify if you...
- QTcF interval 450 ms or higher at screening
- Blood donation or significant blood loss (over 400 ml) within 4 weeks before screening or plans to donate blood during the study
- Receipt of investigational drug or device within 4 weeks before randomization or less than 5 times the drug half-life
- Difficulty with blood collection or intolerance to venipuncture
- History of any cancer
- Allergies to salbutamol, study medications, or formulation ingredients
- Known infection with HIV, hepatitis B or C, or positive tests for these infections before randomization
- History of alcohol or drug abuse or dependence in the past 5 years
- Positive test for alcohol or substance abuse before randomization
- Planned surgery or treatment interfering with study during participation
- Inability or unwillingness to follow study protocol
- Mental or legal incapacity
- Use of strong/moderate CYP3A4 enzyme inhibitors or inducers within 14 days before first dose
- Anticipated use of drugs affecting P-glycoprotein or breast cancer resistance protein during study
- Previous use of HRS-9821 suspension
- For healthy subjects: recent antibiotic treatment for respiratory infections within 12 weeks, abnormal lab or physical exam with clinical significance, positive urine nicotine test, recent use of prescription or over-the-counter drugs before first dose
- For COPD patients: history of life-threatening acute exacerbation, other respiratory disorders, pulmonary heart disease or pulmonary hypertension caused by lung disease or hypoxia, lung surgeries affecting function, recent acute exacerbations requiring steroids or antibiotics or hospitalization, recent lower respiratory infection needing antibiotics, need for oxygen or home ventilation, use or planned use of non-selective beta blockers or bronchoconstrictive drugs, recent serious trauma or major surgery still recovering, abnormal lab tests at screening and baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
Research Team
H
Huanhuan Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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