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NCT07256301
A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Phase 1 trial testing EA5 in PNH - Paroxysmal Nocturnal Hemoglobinuria in 24 participants. Currently enrolling.
1 March 2026
Quick facts
| Lead sponsor | Shanghai Lanyi Therapeutics Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 3 January 2024 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 May 2026 |
| Sites | 2 locations across China |
Drugs / interventions tested
- EA5 — full drug profile →
Conditions studied
- PNH - Paroxysmal Nocturnal Hemoglobinuria — all drugs for PNH - Paroxysmal Nocturnal Hemoglobinuria →
Sponsor
Shanghai Lanyi Therapeutics Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with PNH - Paroxysmal Nocturnal Hemoglobinuria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07256301
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of EA5
Trials testing the same drug.
- NCT07256288 — A Phase Ia Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of EA5 in Healthy Ad · Phase 1 · completed
Other recruiting trials for PNH - Paroxysmal Nocturnal Hemoglobinuria
Currently open trials in the same condition.
- NCT06978699 — A Phase II Study Evaluating the Efficacy and Safety of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobin · Phase 2 · recruiting
- NCT07212426 — Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in PNH Patients. · Phase 2 · active not recruiting
Other Shanghai Lanyi Therapeutics Co., Ltd. trials
Trials by the same sponsor.
- NCT07256288 — A Phase Ia Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of EA5 in Healthy Ad · 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 NCT07256301 (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 Shanghai Lanyi Therapeutics Co., Ltd.
- Last refreshed: 1 December 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/NCT07256301.
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