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This is a single-site study to evaluate the safety, tolerability and pharmacokinetics (PK) of single dose administration of HRS4800, and the effect of food on the PK of HRS4800 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS4800 tablets cohort 1 | Experimental | Part 1 - HRS4800 Single Ascending Dose |
|
| HRS4800 tablets cohort 2 | Experimental | Part 1 - HRS4800 Single Ascending Dose |
|
| HRS4800 tablets cohort 3 | Experimental | Part 1 - HRS4800 Single Ascending Dose |
|
| HRS4800 tablets cohort 4 | Experimental | Part 1 - HRS4800 Single Ascending Dose |
|
| HRS4800 tablets cohort 5 | Experimental | Part 2 - HRS4800 Food Effect |
|
| Placebo tablets | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS4800 tablets | Drug | single oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 - HRS4800 Single Dose Escalation - Safety | • Safety: Incidence and severity of adverse events (AEs), vital signs (pulse rate, respiratory rate, blood pressure, body temperature), physical examination, laboratory tests, electrocardiogram (ECG), etc. | 14 days |
| Part 2 - HRS4800 Food Effect | • PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-t | 21 days |
| Part 2 - HRS4800 Food Effect | • PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-∞ | 21 days |
| Part 2 - HRS4800 Food Effect | • PK parameters of HRS4800 and its active drug SHR175593 in plasma: Tmax、 | 21 days |
| Part 2 - HRS4800 Food Effect | • PK parameters of HRS4800 and its active drug SHR175593 in plasma: Cmax | 21 days |
| Part 2 - HRS4800 Food Effect | • PK parameters of HRS4800 and its active drug SHR175593 in plasma: t1/2、CL/F、Vz/F. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 - HRS4800 Single Dose Escalation - PK | • PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-t | 14 days |
| Part 1 - HRS4800 Single Dose Escalation - PK | AUC0-∞、 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Na Li | Jiangsu Hengrui Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Nedlands | Western Australia | Australia |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The study consists of 2 parts: single dose escalation (Part 1) with four cohorts and food effect on HRS4800 PK (Part 2) with one cohort. All cohorts can enroll healthy male subjects
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Double-blind
| Placebo tablets | Drug | single oral administration |
|
| 14 days |
| Part 1 - HRS4800 Single Dose Escalation - PK | Tmax | 14 days |
| Part 1 - HRS4800 Single Dose Escalation - PK | Cmax | 14 days |
| Part 1 - HRS4800 Single Dose Escalation - PK | t1/2 | 14 days |
| Part 1 - HRS4800 Single Dose Escalation - PK | CL/F、Vz/F. | 14 days |