Status:
COMPLETED
A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration
Lead Sponsor:
Guangdong Hengrui Pharmaceutical Co., Ltd
Conditions:
Chronic Cough
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomiz...
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent.
- Age 18 to 55 years (inclusive).
- Weight of male subjects ≥50 kg, female ≥45kg, body mass index (BMI) 19-26 kg/m2 (inclusive).
- Medical examination (including physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound and chest radiography) normal or abnormal with no clinical significance.
Exclusion
- Any clinically serious diseases such as circulatory, endocrine, nervous, digestive, respiratory, blood, immune, mental and metabolic abnormalities or any other diseases that investigator determines may interfere with the test results.
- Subjects with severe infection, severe trauma or major surgical operation within 3 months prior to screening; Subjects who plan to undergo surgery during the trial period and within two weeks after the trial.
- Treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration.
- Subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator.
- Subjects enrolled in clinical trials of any drug or medical device within 3 months prior to screening, or within 5 half-lives of the drug before screening.
- Subjects who had a history of smoking in the previous 3 months (average daily smoking \> 5 cigarettes), or who could not stop using any tobacco products during the test period.
- Subjects who consumed more than 15g of alcohol per day on average (15g of alcohol is equivalent to 450 mL beer, 150 mL wine or about 50mL low-alcohol white wine) or tested positive for alcohol during the 3 months prior to screening, or who could not abstain from alcohol during the test period.
- Subjects with a history of drug abuse, drug dependence or positive drug screening.
- Determined by the investigator to be unfit to participate in this clinical trial.
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05274516
Start Date
March 28 2022
End Date
October 25 2022
Last Update
April 5 2023
Active Locations (1)
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1
The second hospital of Anhui Medical University
Hefei, Anhui, China, 510120