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The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function. The study was divided into three parts:
Part 1: single ascending dose, randomized, double-blind study,with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions; Part 2: Multiple ascending dose, randomized, double-blind study,with 4 dose groups preset; Part 3: an open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS -5965 compared to demographically-matched healthy participants with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | single ascending dose, randomized, double-blind study,with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions. The food impact study consisted of 10 subjects, 8 of whom received HRS-5965 tablets and 2 of whom received placebo. The remaining cohorts required 8 subjects each, with 6 receiving HRS-5965 tablets and 2 receiving placebo. |
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| Part 2 | Experimental | Multiple ascending dose, randomized, double-blind study,with 4 dose groups preset; Each dose group consisted of 8 healthy adult subjects randomly assigned 6:2 to HRS-5965 tablets or placebo. |
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| Part 3 | Experimental | an open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS -5965 compared to demographically-matched healthy participants with normal renal function. Subjects took HRS5965 tablets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5965 | Drug | Subjects took HRS5965 tablets in Part 1, Part 2 and Part 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events to assess safety and tolerability | up to 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) on Day 1 for Part 1 and Part 3 | Pre-dose to 144 hours post-dose | |
| Peak plasma concentration (Cmax) on Day 1 for Part 1 and Part 3 | Pre-dose to 144 hours post-dose |
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Inclusion Criteria:
- Healthy subjects study
Study on subjects with renal insufficiency
Exclusion Criteria:
- Healthy subjects study
Study on subjects with renal insufficiency
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated hospital of QingDao University | Qingdao | Shandong | 266000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40378845 | Derived | Xu Y, Tian F, Ren H, Yu X, Chen X, Ye K, Sun F, Fang L, Li Y, Ban R, Jiang X, Wang C, Ma Y, Kuang F, Li X, Zhang Z, Ye C, Hu M, He F, Shu C, Zou Y, Huang R, Shen K, Xing G, Cao Y. HRS-5965, a small-molecule factor B inhibitor, in healthy participants and participants with renal insufficiency: A first-in-human, phase 1 trial. Med. 2025 Aug 8;6(8):100698. doi: 10.1016/j.medj.2025.100698. Epub 2025 May 15. |
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| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Single-dose and multi-dose, dose escalation, placebo-controlled study
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| Placebo | Drug | Subjects took Placebo in Part 1 and Part 2. |
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| Time to maximum plasma concentration (Tmax) on Day 1 for Part 1 and Part 3 | Pre-dose to 144 hours post-dose |
| • Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 10 for Part 2 | Pre-dose to 144 hours post-dose |
| Peak plasma concentration (Cmax) on Day 1 and Day 10 for Part 2 | Pre-dose to 144 hours post-dose |
| Time to maximum plasma concentration (Tmax) on Day 1 and Day 10 for Part 2 | Pre-dose to 144 hours post-dose |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |