Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects and COPD Patients

NCT05622864 | Completed Phase 1

• 1 other identifier: HRS-9821-I-101
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Assess the incidence and severity of adverse events after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.

  About a month from the first medication to the evaluation.

Secondary Outcomes (13)

• Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.

  2 hours after the first dose

• Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.

  4 hours after the first dose

• Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.

  6 hours after the first dose

• Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.

  12 hours after the first dose

• Evaluate the forced expiratory volume in one second (FEV1) after single atomization inhalation of HRS-9821 in healthy subjects and multiple atomization inhalation of HRS-9821 in COPD patients.

  24 hours after the first dose

Study Arms (2)

Part A

EXPERIMENTAL

Drug: HRS-9821

Part B

EXPERIMENTAL

Drug: HRS-9821

Interventions

HRS-9821 DRUG

HRS-9821

Part A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Healthy subjects: in the past 12 weeks, antibiotics have been used for upper and lower respiratory tract infections, or have a history of respiratory infections within the past 4 weeks; COPD patients: in the past 4 weeks, antibiotics have been used for lower respiratory tract infections;
• Healthy subjects: abnormal laboratory or physical examination results of clinical significance;
• The average value of QTcF for 3 times at screening is ≥450ms;
• In the past four weeks, there have been blood donations or large blood loss (more than 400 milliliters), or those who intentionally donate blood during the study;
• Accept experimental drugs or use experimental medical devices within 1 months or less than 5 times the half-life of the drug, whichever is longer;
• In the past, there were difficulties in collecting blood or could not withstand intravenous puncture, such as needle halo and blood halo
• Any organ system has a history of malignant tumors;
• Known to be allergic to any accessories in the research drug or formulation;
• Previously known infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) liver or hepatitis C virus (HCV); or randomized pre-HIV (according to the test center SOP), treponema pallidum antibody (TPPA), HBV surface antigen or HCV antibody positive;
• There is a history of smoking and alcoholism in the 3 months before screening: smoking (more than 5 cigarettes or equivalent tobacco per day); alcoholism (more than 14 units of alcohol per week: 1 unit = 360 mL of beer, or 25 mL of spirits with a concentration of 40% or more, or 1 glass of wine, 180mL);
• In the past five years, there has been a history of drug abuse and drug dependence;
• Before randomization, positive for alcohol or drug abuse or nicotine in urine;
• During the study, there is a surgical plan or may interfere with the treatment plan carried out by the study;
• Inability or unwillingness to fully comply with the research program;
• Mentally or legally incapacitated;

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

West China Hospital，Sichuan University

Chengdu, Sichuan, 610044, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 21, 2022
• Study Start: January 12, 2023
• Primary Completion: May 7, 2025
• Study Completion: June 16, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

CN (1)