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NCT05505955
Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency
Phase 1 trial testing HRS-5965 in Glomerulonephritis in 83 participants. Completed in 3 November 2023.
3 November 2023
Quick facts
| Lead sponsor | Chengdu Suncadia Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 83 |
| Start date | 8 October 2022 |
| Primary completion | 3 November 2023 |
| Estimated completion | 3 November 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- HRS-5965 — full drug profile →
- Placebo
Conditions studied
- Glomerulonephritis — all drugs for Glomerulonephritis →
Sponsor
Chengdu Suncadia Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 70, any sex, with Glomerulonephritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
HRS-5965, a small-molecule factor B inhibitor, in healthy participants and participants with renal insufficiency: A first-in-human, phase 1 trial.
Xu Y, Tian F, Ren H, Yu X, et al · · 2025 · cited 2× · PMID 40378845 · DOI 10.1016/j.medj.2025.100698
Verify or expand the search:
- PubMed search for NCT05505955
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HRS-5965
Trials testing the same drug.
- NCT06137768 — A Trial of HRS-5965 Tablets in Primary IgA Nephropathy · Phase 2 · active not recruiting
Other recruiting trials for Glomerulonephritis
Currently open trials in the same condition.
- NCT06858319 — Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy. · Phase 3 · recruiting
- NCT06835322 — Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis · Phase 2 · recruiting
- NCT04662723 — Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy. · Phase 4 · recruiting
- NCT05434325 — TESTING -ON Post-Trial ObservatioNal Cohort Study · recruiting
- NCT04663204 — A Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropath · Phase 2 · active not recruiting
Other Chengdu Suncadia Medicine Co., Ltd. trials
Trials by the same sponsor.
- NCT07040787 — Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects · Phase 1 · completed
- NCT07035665 — A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects · Phase 1 · completed
- NCT06715943 — Efficacy and Safety of HRS-5965 in Patients With PNH Who Are Still Anemia After Anti-C5 Antibody Treatment · Phase 3 · completed
- NCT06674915 — Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment · Phase 1 · completed
- NCT06684041 — A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Sub · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05505955 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chengdu Suncadia Medicine Co., Ltd.
- Last refreshed: 23 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05505955.
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