Actively Recruiting
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder and Inhalation Suspension in Healthy Adults and Patients with COPD
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2026-02-27
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 drug's effects and tolerability.
CONDITIONS
Brief 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 in the trial
- Body weight of at least 45 kg and BMI between 18 and 33 kg/m2
- Normal or clinically insignificant 12-lead ECG until randomization
- Strict contraception from consent until 1 month after last dose for HRS-9821/placebo or 3 months after last dose for male moxifloxacin recipients
- Correct use of inhalation devices and adherence to study procedures
- For healthy subjects: normal vital signs and lung function, no smoking or quit over 12 months ago with less than 5 pack-years history, male aged 18 to 50 years
- For COPD subjects: male or female aged 40 to 75 years
- Diagnosed COPD with post-bronchodilator FEV1/FVC less than 0.7 and FEV1 between 40% and 80% predicted
- Smoking history of at least 10 pack-years
- Normal chest X-ray at screening
- Willing to discontinue COPD-related medications before randomization
You will not qualify if you...
- QTcF interval of 450 ms or more at screening
- Blood donation or significant blood loss (>400 ml) within 4 weeks before screening
- Use of investigational drug or device within 4 weeks before randomization
- Difficulty or intolerance to blood collection
- History of any malignancy
- Allergies to salbutamol, study medication, or ingredients
- Known HIV, hepatitis B or C infection, or positive viral tests before randomization
- History of alcohol or drug abuse within past 5 years
- Positive alcohol or substance abuse test before randomization
- Planned surgery or treatment interfering with the study
- Inability or unwillingness to follow the study protocol
- Mental or legal incapacity
- Use of strong/moderate CYP3A4 enzyme inhibitors or inducers within 14 days before first dose
- Use of drugs affecting P-glycoprotein or BCRP during the study
- Prior use of HRS-9821 suspension
- For healthy subjects: recent antibiotic treatment for respiratory infections, abnormal labs or physical exams, positive urine nicotine test, recent use of prescription or over-the-counter drugs
- For COPD subjects: history of life-threatening COPD exacerbations, other respiratory disorders, pulmonary heart disease, lung surgery affecting function, recent acute COPD exacerbations or infections, oxygen therapy or home ventilation, use of non-selective beta blockers or bronchoconstrictive drugs, recent major trauma or surgery, abnormal lab tests at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 days
Participants receive either a single dose or 12 consecutive days of inhaled HRS-9821 powder or inhalation suspension, placebo, or oral Moxifloxacin depending on their group assignment.
1 baseline visit and daily visits during treatment
Duration - Up to 40 days after treatment administration
Participants are monitored for safety, drug concentrations, and heart and lung function changes after treatment.
Multiple visits over follow-up period
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
Research Team
H
Huanhuan Huang
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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