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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
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• Informed consent was obtained to participate in the trial

• Body weight ≥45 kg, BMI 18-33 kg/m2 (both ends included)

• The 12-lead ECG was normal or abnormal but clinically insignificant until randomization

• Contraception was strict from the time informed consent was signed until 1 month (for subjects receiving HRS-9821/ placebo) or 3 months (for male subjects receiving moxifloxacin) after the last dose

• All study regulations and procedures were followed and inhalation devices used in the study were used correctly during the study

• The following inclusion criteria apply only to healthy subjects:

• Vital signs were normal at screening

• Pulmonary function was normal during screening

• No smoking or smoking cessation ≥12 months before screening, and previous smoking history \<5 pack-years;

• Healthy male 18-50 years old The following inclusion criteria apply only to subjects with COPD

⁃ Male or female, aged 40-75 years;

⁃ Patients diagnosed with COPD;

⁃ A post-bronchodilator FEV1 /FVC \< 0.7,40% ≤FEV1 \< 80% of the predicted value,;

⁃ Smoking history of≥ 10 pack-years;

⁃ Normal chest X-ray examination results at screening;

⁃ Supporting discontinuation of COPD-related medications before randomization;

Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Huanhuan Huang
huanhuan.huang.hh30@hengrui.com
+0518-81220121
Time Frame
Start Date: 2025-08-11
Estimated Completion Date: 2026-01
Participants
Target number of participants: 82
Treatments
Experimental: HRS-9821 Powder for Inhalation
Participants inhaled HRS-9821 powder either as a single dose or for 12 days.
Placebo_comparator: HRS-9821 Powder for Inhalation placebo
Participants received a single dose or 12 consecutive days of inhaled powdered placebo with HRS-9821.
Active_comparator: Moxifloxacin
Moxifloxacin is oral
Sponsors
Leads: Guangdong Hengrui Pharmaceutical Co., Ltd

This content was sourced from clinicaltrials.gov