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

Guangdong Hengrui Pharmaceutical Co., Ltd1 site in 1 country92 target enrollmentMarch 28, 2022

ConditionsChronic Cough

InterventionsHRS-2261 tablet、placebo

DrugsHRS-2261 tablet、placebo

Overview

Phase: Phase 1
Intervention: HRS-2261 tablet、placebo
Conditions: Chronic Cough
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Enrollment: 92
Locations: 1
Primary Endpoint: Number and severity of treatment emergent adverse events (TEAEs)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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, 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.

Registry

clinicaltrials.gov

Start Date

March 28, 2022

End Date

October 25, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Single Ascending Doses, 6 dose levels

HRS-2261 oral tablet Matching placebo to HRS-2261

Intervention: HRS-2261 tablet、placebo

Multiple Ascending Doses, 3 dose levels

HRS-2261 oral tablet Matching placebo to HRS-2261

Intervention: HRS-2261 tablet、placebo

Outcomes

Primary Outcomes

Number and severity of treatment emergent adverse events (TEAEs)

Time Frame: up to 7 days after the last dose

Number and severity of TEAEs collected from dosing until follow up 7 days after last dose

Secondary Outcomes

Maximum plasma concentration (Cmax)(up to 7 days after the last dose)
Area under the curve (AUC)(up to 7 days after the last dose)
Maximum plasma concentration (Cmax) under fed conditions(up to 7 days after the last dose)
Area under the curve (AUC) under fed conditions(up to 7 days after the last dose)