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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HRS-9821
HRS-9821
Sponsored by
Guangdong Hengrui Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Sign an informed consent forms; Healthy men aged 18-50 (both ends, subject to the signing of the informed consent form); Weight ≥50 kg,BMI 18-33 kg/m2 (include 33 kg/m2); During the screening period, the vital signs are normal: Shrinkage 90-140 mmHg, diastolic pressure 50-90 mmHg, Heart rate 40-100 times/min; 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%; 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; Non-smoking or quitting smoking ≥ 12 months, the previous smoking history < 5 packs of years. Exclusion Criteria: 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; 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 3 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 = 360mL of beer, or 25mL 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; The researchers believe that there are any other reasons why the subjects are unfit to participate in the study; Prescription was used within 14 days before the first administration or within 48 hours before the first administration; 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; During the study, it was expected to use drugs that had an effect on P-gp or breast cancer drug-resistant protein (BCRP)

Sites / Locations

  • West China Hospital,Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PartA

PartB

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the forced expiratory volume in one second (FEV1) of healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the average value of FEV1 compared with baseline changes in healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate the change of FEV1 peak in healthy subjects after single and multiple atomization inhalation of HRS-9821 compared with the baseline
Evaluate the force lung capacity(FVC) of healthy subjects after single and multiple atomized inhalation of HRS-9821
Evaluate pharmacokinetics concentration and pharmacokinetic parameters of healthy subjects after single and multiple atomization inhalation of HRS-9821

Full Information

First Posted
November 14, 2022
Last Updated
April 25, 2023
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05622864
Brief Title
Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sign an informed consent forms; Healthy men aged 18-50 (both ends, subject to the signing of the informed consent form); Weight ≥50 kg,BMI 18-33 kg/m2 (include 33 kg/m2); During the screening period, the vital signs are normal: Shrinkage 90-140 mmHg, diastolic pressure 50-90 mmHg, Heart rate 40-100 times/min; 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%; 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; Non-smoking or quitting smoking ≥ 12 months, the previous smoking history < 5 packs of years. Exclusion Criteria: 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; 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 3 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 = 360mL of beer, or 25mL 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; The researchers believe that there are any other reasons why the subjects are unfit to participate in the study; Prescription was used within 14 days before the first administration or within 48 hours before the first administration; 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; During the study, it was expected to use drugs that had an effect on P-gp or breast cancer drug-resistant protein (BCRP)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Chen, M.D
Phone
0518-82342973
Email
hong.chen@hengrui.com
Facility Information:
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu Luo, Doctor
Phone
028-85423237
Email
luozhu720@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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