A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia
NCT06772766 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-01-14
Summary
This is a phase Ib, randomized, double-blind, placebo-controlled, multiple ascending dose study . The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics(PK), pharmacodynamics(PD), and immunogenicity of 9MW3011 in patients with non-transfusion-dependent β- thalassemia .
Conditions
Interventions
- DRUG
-
9MW3011
Ascending IV doses administered per protocol
- DRUG
-
9MW3011 placebo
Ascending IV doses administered per protocol
Sponsors & Collaborators
-
Mabwell (Shanghai) Bioscience Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-30
- Primary Completion
- 2026-10-31
- Completion
- 2026-10-31
Countries
- China
Study Locations
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