A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration

  • STATUS
    Recruiting
  • days left to enroll
    34
  • participants needed
    92
  • sponsor
    Guangdong Hengrui Pharmaceutical Co., Ltd
Updated on 2 May 2022
Accepts healthy volunteers

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, randomized study design. The influence of food on the pharmacokinetics of HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.

Details
Condition Chronic Cough
Treatment HRS-2261 tablet、placebo
Clinical Study IdentifierNCT05274516
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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