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NCT05828472
A Study of Multiple Ascending Doses MY008211A in Healthy Adults
Phase 1 trial testing MY008211A tablets in Paroxysmal Nocturnal Hemoglobinuria in 40 participants. Completed in 30 June 2023.
30 June 2023
Quick facts
| Lead sponsor | Wuhan Createrna Science and Technology Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 10 January 2023 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- MY008211A tablets — full drug profile →
- MY008211A tablets matched placebo — full drug profile →
Conditions studied
- Paroxysmal Nocturnal Hemoglobinuria — all drugs for Paroxysmal Nocturnal Hemoglobinuria →
Sponsor
Wuhan Createrna Science and Technology Co., Ltd — full company profile →
Who can join
Adults 18 to 45, any sex, with Paroxysmal Nocturnal Hemoglobinuria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation, and multiple-dose study to evaluate safety, tolerability, PK and PD of MY008211A Tablets in healthy subjects.
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 NCT05828472
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MY008211A tablets
Trials testing the same drug.
- NCT06687174 — Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN) · Phase 2 · not yet recruiting
- NCT06933914 — Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 2, PHASE3 · recruiting
- NCT06932744 — Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complem · Phase 3 · recruiting
- NCT06932471 — Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment · Phase 3 · recruiting
- NCT06543459 — To Evaluate the Effect of Single Oral Dose of MY008211A Tablets on QTc Interval in Healthy Subjects · Phase 1 · not yet recruiting
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 Wuhan Createrna Science and Technology Co., Ltd trials
Trials by the same sponsor.
- NCT06687174 — Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN) · Phase 2 · not yet recruiting
- NCT06716970 — QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension · Phase 3 · not yet recruiting
- NCT06933914 — Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 2, PHASE3 · recruiting
- NCT06932744 — Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complem · Phase 3 · recruiting
- NCT06932471 — Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment · Phase 3 · recruiting
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 NCT05828472 (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 Wuhan Createrna Science and Technology Co., Ltd
- Last refreshed: 8 September 2023
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/NCT05828472.
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