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NCT06684041
A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects
Phase 1 trial testing HRS-5965 capsule in Hemolytic Anemia in 32 participants. Completed in 7 April 2025.
7 April 2025
Quick facts
| Lead sponsor | Chengdu Suncadia Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 9 November 2024 |
| Primary completion | 7 April 2025 |
| Estimated completion | 7 April 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- HRS-5965 capsule
- HRS-5965 capsule placebo
Conditions studied
- Hemolytic Anemia — all drugs for Hemolytic Anemia →
Sponsor
Chengdu Suncadia Medicine Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with Hemolytic Anemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This was a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. This study plans to conduct three dose groups of dose 1, dose 2, and dose 3. A total of 32 healthy subjects were planned to be enrolled.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06684041
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HRS-5965 capsule
Trials testing the same drug.
- NCT06715943 — Efficacy and Safety of HRS-5965 in Patients With PNH Who Are Still Anemia After Anti-C5 Antibody Treatment · Phase 3 · completed
- NCT06593938 — A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients · Phase 3 · completed
Other recruiting trials for Hemolytic Anemia
Currently open trials in the same condition.
- NCT04610866 — Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickl · Phase 1, PHASE2 · 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
- NCT06593938 — A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients · Phase 3 · 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 NCT06684041 (US National Library of Medicine, public domain)
- 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: 4 July 2025
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/NCT06684041.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing