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A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of HRS-2261, the Effects of Food on the Pharmacokinetics of HRS-2261, and the Effects of HRS-2261 on CYP3A4 Metabolic Enzymes in Healthy Subjects After Single and Multiple Oral Administration

NCT05274516•Guangdong Hengrui Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Able and willing to provide a written informed consent.
•2. Age 18 to 55 years (inclusive).
•3. Weight of male subjects ≥50 kg, female ≥45kg, body mass index (BMI) 19-26 kg/m2 (inclusive).
•4. 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

•1. 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.
•2. 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.
•3. Treated with any drug that inhibits or induces drug metabolism in the liver within 1 month prior to administration.
•4. Subjects have any condition or medical condition that affects absorption, metabolism, and/or excretion of the study drug according to the investigator.
•5. 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.
•6. 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.
•7. 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.
•8. Subjects with a history of drug abuse, drug dependence or positive drug screening.
•9. Determined by the investigator to be unfit to participate in this clinical trial.

Locations (1)

The second hospital of Anhui Medical University

Hefei, Anhui, China

Key Dates

Start Date

March 28, 2022

Primary Completion Date

October 25, 2022

Completion Date

October 25, 2022

Last Updated

April 5, 2023

Enrollment

ACTUAL participants

Conditions

Chronic Cough

Interventions

HRS-2261 tablet、placebo

DRUG

HRS-2261 tablet、placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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