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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Safety, Tolerance, Pharmacokinetics and Pharmacodynamics Phase I Study of Increased Doses of Single and Multiple Atomized Inhalation of HRS-9821 Suspension for Inhalation in Healthy People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622864
• Other study ID #: HRS-9821-I-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 12, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2023
• Source: Guangdong Hengrui Pharmaceutical Co., Ltd
• Contact: Hong Chen, M.D
• Phone: 0518-82342973
• Email: hong.chen[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Sign an informed consent forms;

2. Healthy men aged 18-50 (both ends, subject to the signing of the informed consent form);

3. Weight =50 kg,BMI 18-33 kg/m2 (include 33 kg/m2);

4. During the screening period, the vital signs are normal:

• Shrinkage 90-140 mmHg,

• diastolic pressure 50-90 mmHg,

• Heart rate 40-100 times/min;

5. During the screening period, the lung function is normal, that is, the predicted value of FEV1=80% and the predicted value of FEV1/FVC=92%;

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

7. 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;

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

9. Non-smoking or quitting smoking = 12 months, the previous smoking history < 5 packs of years.

Exclusion Criteria:

1. 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;

2. Abnormal laboratory or physical examination results of clinical significance

3. The average value of QTcF for 3 times at screening is =450ms;

4. 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

5. Accept experimental drugs or use experimental medical devices within 3 months or less than 5 times the half-life of the drug, whichever is longer;

6. In the past, there were difficulties in collecting blood or could not withstand intravenous puncture, such as needle halo and blood halo

7. Any organ system has a history of malignant tumors;

8. Known to be allergic to any accessories in the research drug or formulation;

9. 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;

10. 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 = 360mL of beer, or 25mL of spirits with a concentration of 40% or more, or 1 glass of wine, 180mL);

11. In the past five years, there has been a history of drug abuse and drug dependence.

12. Before randomization, positive for alcohol or drug abuse or nicotine in urine.

13. During the study, there is a surgical plan or may interfere with the treatment plan carried out by the study;

14. Inability or unwillingness to fully comply with the research program;

15. Mentally or legally incapacitated;

16. The researchers believe that there are any other reasons why the subjects are unfit to participate in the study;

17. Prescription was used within 14 days before the first administration or within 48 hours before the first administration;

18. Drugs that have used strong/intermediate inhibitors or induce liver drug metabolic enzyme CYP3A4 14 days before the first administration or ingest grapefruit or related products within 7 days before the first administration;

19. During the study, it was expected to use drugs that had an effect on P-gp or breast cancer drug-resistant protein (BCRP)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Drug:
• HRS-9821
HRS-9821
• HRS-9821
HRS-9821

Locations

Country	Name	City	State
China	West China Hospital,Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Hengrui Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the incidence and severity of adverse events after single and multiple atomization inhalation of HRS-9821 in healthy subjects		About a month from the first medication to the evaluation.
Secondary	Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821		2 hours after the first dose
Secondary	Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821		4 hours after the first dose
Secondary	Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821		6 hours after the first dose
Secondary	Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821		12 hours after the first dose
Secondary	Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821		24 hours after the first dose
Secondary	Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821		2 hours after the first dose
Secondary	Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821		3 hours after the first dose
Secondary	Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821		4 hours after the first dose
Secondary	Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821		12 hours after the first dose
Secondary	Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821		24 hours after the first dose
Secondary	Evaluate the change of FEV1 peak in healthy subjects after single and multiple atomization inhalation of HRS-9821 compared with the baseline		About 24 hours after the first dose
Secondary	Evaluate the force lung capacity(FVC) of healthy subjects after single and multiple atomized inhalation of HRS-9821		2 hours after the first dose
Secondary	Evaluate pharmacokinetics concentration and pharmacokinetic parameters of healthy subjects after single and multiple atomization inhalation of HRS-9821		2 weeks after the first dose