Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Assess Safety and Effects of 9MW3011 by Intravenous Infusion in Patients with Non-transfusion-dependent Beta-Thalassemia
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-01-14
40
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of an experimental drug called 9MW3011 in adults with non-transfusion-dependent beta-thalassemia. This phase Ib study involves patients aged 18 to 65 who have a genetic diagnosis of beta-thalassemia or hemoglobin E/beta-thalassemia, with a specific range of baseline hemoglobin and evidence of iron overload. The study aims to better understand how this drug behaves in the body and its potential effects in this patient population. A total of 40 participants will be divided into four groups receiving different ascending intravenous doses of 9MW3011 or placebo in a 4:1 ratio. Each group will receive multiple doses according to the study protocol. The study is randomized, double-blind, and placebo-controlled to ensure unbiased assessment of the drug's effects compared to placebo. Participants will be closely monitored up to day 169 for adverse events, changes in vital signs, physical examinations, 12-lead electrocardiogram (ECG) parameters, and laboratory test results. The study includes detailed evaluations of safety and tolerability along with laboratory and clinical assessments to track any significant changes. The total participation duration covers screening, treatment, and follow-up periods to gather comprehensive safety and pharmacological data.
CONDITIONS
Official Title
A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 to 65 years (inclusive)
- Documented genetic diagnosis of beta-thalassemia or hemoglobin E/beta-thalassemia
- Meet criteria for non-transfusion-dependent thalassemia
- Baseline hemoglobin level between 70-100 g/L based on two measurements at least 1 week apart within 4 weeks before randomization
- Evidence of iron overload during screening
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
- Understand study procedures, voluntarily participate, and sign informed consent
You will not qualify if you...
- Diagnosed with alpha-thalassemia
- Diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
- Severe iron overload at screening
- Other forms of anemia or hematological disorders that may affect safety or study outcomes
- Significant systemic diseases or psychiatric disorders
- New York Heart Association (NYHA) Class III-IV heart failure or other cardiovascular diseases within 6 months prior to screening or currently present
- QTcF interval ≥450ms for males or ≥470ms for females on 12-lead ECG or clinically significant abnormal ECG
- Uncontrolled hypertension before screening
- History of malignant neoplasm within the last 5 years
- Severe infection requiring hospitalization or intravenous antimicrobial therapy or uncontrolled systemic infection
- Received treatment not permitted by protocol
- Hematological parameters not meeting inclusion criteria during screening
- History of substance abuse or positive substance abuse screening
- Unable to undergo MRI scans
- Pregnant or lactating women
- Other factors deemed unsuitable by investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The first Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
2
Hainan General Hospital
Haikou, Hainan, China, 570311
Actively Recruiting
Research Team
Y
Yongrong Lai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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