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This study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of HS-10383 in healthy subjects using a randomized, double blind, placebo controlled, single center study design.
HS-10383 is a selective P2X3 receptor antagonist being developed for the treatment of refractory/unexplained chronic cough. This Phase 1b study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of HS-10383 administered orally to healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10383 (Multiple doses) | Experimental | Escalating doses of HS-10383 administered orally once daily for a week in healthy participants. |
|
| HS-10383 Placebo (Multiple doses) | Placebo Comparator | Escalating doses of HS-10383 Placebo administered orally daily for a week in healthy participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10383 | Drug | HS-10383 administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of treatment emergent adverse events | Safety and Tolerability Evaluation | up to 15 days |
| Number of participants experiencing AE with abnormal laboratory values | Safety and Tolerability Evaluation | up to 15 days |
| Number of participants experiencing AE with abnormal Electrocardiograph | Safety and Tolerability Evaluation | up to 15 days |
| Safety and Tolerability Evaluation | Number of participants experiencing AE with abnormal vital sign | up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To assess Cmax of Multiple ascending oral doses of HS-10383 | up to 192 hours after the last dose |
| Area under the curve (AUC) | o assess AUC of Multiple ascending oral doses of HS-10383 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong provincial qianfoshan hospital | Recruiting | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| HS-10383 Placebo | Drug | HS-10383 Placebo administered as one 50 mg, 150 mg, 300 mg and 450 mg capsule once daily, depending upon randomization. |
|
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| up to 192 hours after the last dose |
| Time of Maximum Concentration (Tmax) | To assess Tmax of Multiple ascending oral doses of HS-10383 | up to 192 hours after the last dose |
| D013568 | Pathological Conditions, Signs and Symptoms |