Chronic Cough
Conditions
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.
Interventions
DRUGHRS-2261 tablet、placebo
HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose.
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HRS-2261 compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) 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) 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 |
Countries
China
Outcome results
None listed