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The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-7085 tablets Cohort 1 | Experimental | Part 1- HRS-7085 tablets |
|
| HRS-7085 tablets Cohort 6 | Experimental | Part 1- HRS-7085 tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7085 tablets | Drug | Single oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Start of Treatment to end of study approximately 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-AUC0-last | Area under the concentration-time curve from time 0 to last time point after HRS-7085 administration | Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Part 1: HRS-7085 Single Ascending Dose (SAD) Both males and females are planned to be enrolled in five cohorts (optional and determined by Safety Review Committee (SRC) in this SAD study Part 2: Food Effect: Participants in cohort 3 who have finished the follow-up visit will be involved in the food effect study after safety evaluation by the investigator.
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| Placebo tablet | Drug | Single oral administration |
|
Area under the concentration-time curve from time 0 to infinity after HRS-7085 administration
| Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-Tmax | Time to Cmax of HRS-7085 | Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-Cmax | Maximum observed concentration of HRS-7085 | Time Frame: Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-CL/F | Apparent clearance of HRS-7085 | Time Frame: Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of HRS-7085 | Time Frame: Start of Treatment to end of study (approximately 1 week) |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of HRS-7085 | Time Frame: Start of Treatment to end of study (approximately 1 week) |