Who is sponsoring NCT06051357?

NCT06051357 is sponsored by Chengdu Suncadia Medicine Co., Ltd..

What drugs are being tested in NCT06051357?

Interventions in NCT06051357: HRS-5965 tablets.

What condition does NCT06051357 study?

NCT06051357 studies Paroxysmal Nocturnal Hemoglobinuria.

Is NCT06051357 still recruiting?

NCT06051357 is currently completed. Last updated 15 October 2024.

Last reviewed 2024-10-15 · How we verify

NCT06051357

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Completed Phase 2 Last updated 15 October 2024

What this trial tests

Phase 2 trial testing HRS-5965 tablets in Paroxysmal Nocturnal Hemoglobinuria in 26 participants. Completed in 25 March 2024.

Timeline

15 November 2023

Primary endpoint
25 March 2024

25 March 2024

Quick facts

Lead sponsor	Chengdu Suncadia Medicine Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	15 November 2023
Primary completion	25 March 2024
Estimated completion	25 March 2024
Sites	2 locations across China

Drugs / interventions tested

HRS-5965 tablets — full drug profile →

Conditions studied

Paroxysmal Nocturnal Hemoglobinuria — all drugs for Paroxysmal Nocturnal Hemoglobinuria →

Sponsor

Chengdu Suncadia Medicine Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Paroxysmal Nocturnal Hemoglobinuria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, open-label phase II clinical trial. A total of 24 patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HRS-5965 for 12 weeks.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Factor B as a therapeutic target for the treatment of complement-mediated diseases.
Kavanagh D, Barratt J, Schubart A, Webb NJA, et al · · 2025 · cited 10× · PMID 40028332 · DOI 10.3389/fimmu.2025.1537974
Efficacy and safety of HRS-5965 monotherapy in complement inhibitor-naïve patients with paroxysmal nocturnal haemoglobinuria.
Zhang L, Liu Z, Zhao X, Hu B, et al · · 2025 · cited 1× · PMID 40589217 · DOI 10.1111/bjh.20230

Verify or expand the search:

Other recruiting trials for Paroxysmal Nocturnal Hemoglobinuria

Currently open trials in the same condition.

NCT07457151 — Danicopan PMS in Korea · recruiting
NCT07154745 — A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hem · Phase 3 · recruiting
NCT07470762 — Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 1, PHASE2 · recruiting
NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o · active not recruiting
NCT07413679 — Long-term Safety of Danicopan: IPIG Registry-based Cohort Study · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06051357 (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: 15 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/NCT06051357.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing