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.
Recruiting
Phase 1
Interventional Study
COPD
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 160 (estimated)
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Informed consent was obtained to participate in the trial
2. Body weight ≥45 kg, BMI 18-33 kg/m2 (both ends included)
3. The 12-lead ECG was normal or abnormal but clinically insignificant until randomization
4. Contraception was strict from the time informed consent was sign…
Contacts