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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Doses, 6 dose levels | Experimental | HRS-2261 oral tablet Matching placebo to HRS-2261 |
|
| Multiple Ascending Doses, 3 dose levels | Experimental | HRS-2261 oral tablet Matching placebo to HRS-2261 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2261 tablet、placebo | Drug | HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of treatment emergent adverse events (TEAEs) | Number and severity of TEAEs collected from dosing until follow up 7 days after last dose | up to 7 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) | To assess AUC of single and multiple ascending oral doses of HRS-2261 | up to 7 days after the last dose |
| Maximum plasma concentration (Cmax) | To assess Cmax of single and multiple ascending oral doses of HRS-2261 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second hospital of Anhui Medical University | Hefei | Anhui | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38198010 | Derived | Fan Y, Zhang X, Zhang Q, Zheng L, Zhou R, Sun C, Wang X, Song K, He Z, Wang H, Zhang Q, Hu W. Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Clin Pharmacokinet. 2024 Mar;63(3):293-302. doi: 10.1007/s40262-023-01330-7. Epub 2024 Jan 10. |
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| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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HRS-2261 compared with placebo
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| HRS-2261 tablet、placebo | Drug | HRS-2261 oral tablet, oral, BID. Matching placebo to HRS-2261, oral, BID. |
|
| up to 7 days after the last dose |
| Area under the curve (AUC) under fed conditions | To assess AUC of a single oral dose of HRS-2261 under fed conditions | up to 7 days after the last dose |
| Maximum plasma concentration (Cmax) under fed conditions | To assess Cmax of a single oral dose of HRS-2261 under fed conditions | up to 7 days after the last dose |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |