A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration
- Conditions
- Chronic Cough
- Interventions
- Drug: HRS-2261 tablet、placebo
- Registration Number
- NCT05274516
- Lead Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Ascending Doses, 6 dose levels HRS-2261 tablet、placebo HRS-2261 oral tablet Matching placebo to HRS-2261 Multiple Ascending Doses, 3 dose levels HRS-2261 tablet、placebo HRS-2261 oral tablet Matching placebo to HRS-2261
- Primary Outcome Measures
Name Time Method Number and severity of treatment emergent adverse events (TEAEs) 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 Outcome Measures
Name Time Method Area under the curve (AUC) under fed conditions up to 7 days after the last dose To assess AUC of a single oral dose of HRS-2261 under fed conditions
Maximum plasma concentration (Cmax) up to 7 days after the last dose To assess Cmax of single and multiple ascending oral doses of HRS-2261
Area under the curve (AUC) up to 7 days after the last dose To assess AUC of single and multiple ascending oral doses of HRS-2261
Maximum plasma concentration (Cmax) under fed conditions up to 7 days after the last dose To assess Cmax of a single oral dose of HRS-2261 under fed conditions
Trial Locations
- Locations (1)
The second hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China