Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose Escalation of Nebulized Inhalation of HRS-9821 Suspension in Healthy Individuals and Multiple Doses in COPD Patients

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

The increased safety and tolerance of single and multiple atomized inhalation of HRS-9821 suspension for inhalation doses in healthy subjects and COPD patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
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• Sign an informed consent forms;

• Healthy men aged 18-50 (both ends, subject to the signing of the informed consent form); COPD patients aged 40-75 (both ends, subject to the signing of the informed consent form);

• Weight ≥45 kg,BMI 18-33 kg/m2 (include 33 kg/m2);

• During the screening period, the vital signs of healthy subjects are normal:

‣ Shrinkage 90-140 mmHg,

⁃ diastolic pressure 50-90 mmHg,

⁃ Heart rate 40-100 times/min;

• During the screening period, the lung function of healthy subjects is normal, that is, the predicted value of FEV1≥80% and the predicted value of FEV1/FVC≥92%; After COPD patients inhale bronchodilators, he predicted value of FEV1≥40% and the predicted value of FEV1/FVC\<0.7;

• During screening, the 12-lead ECG is normal or abnormal but has no clinical significance.

• Follow the contraceptive requirements within 14 weeks from the beginning of the consent to the last dose, and do not donate sperm during the consent period;

• During the study, all research regulations and procedures can be followed, and the atomization devices used by the research institute can be used correctly;

• Healthy subjects: non-smoking or quitting smoking ≥ 12 months, the previous smoking history \< 5 packs of years; COPD patients: the previous smoking history ≥ 10 packs of years.

Locations
Other Locations
China
West China Hospital,Sichuan University
Chengdu
Time Frame
Start Date: 2023-01-12
Completion Date: 2025-06-16
Participants
Target number of participants: 106
Treatments
Experimental: Part A
Experimental: Part B
Sponsors
Leads: Guangdong Hengrui Pharmaceutical Co., Ltd

This content was sourced from clinicaltrials.gov