Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 9MW3011, a drug being studied in patients with non-transfusion-dependent beta-thalassemia, a condition affecting blood production. This phase Ib, randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, how the drug moves and acts in the body, and immune responses to 9MW3011. The study involves 40 patients divided into four dose groups to explore these effects carefully. Participants will receive either 9MW3011 or a placebo through intravenous infusion in a 4:1 ratio within each dose group. The study has multiple ascending dose cohorts to test increasing doses of 9MW3011. This design helps researchers understand the drug's impact at different dose levels and compare it to a placebo under blinded conditions. During the study, participants will be monitored up to day 169 for adverse events, vital signs, physical exams, ECG results, and lab tests to evaluate safety. Researchers will measure drug levels in the blood, effects on iron metabolism markers, immune responses, and liver iron concentration. Participants will be involved in scheduled visits for assessments, tests, and safety monitoring throughout the study duration.
CONDITIONS
Brief 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 and 100 g/L based on 2 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
- Ability to understand study procedures, voluntarily participate, and sign informed consent form
You will not qualify if you...
- Diagnosis of alpha-thalassemia
- Diagnosis of HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
- Severe iron overload at screening
- Other anemia or hematological disorders that may affect safety or outcomes
- Significant systemic diseases or psychiatric disorders
- New York Heart Association (NYHA) Class III-IV heart failure or cardiovascular diseases within 6 months prior or currently present
- QTcF interval ≥450ms for males or ≥470ms for females on ECG or clinically significant abnormal ECG
- Uncontrolled hypertension before screening
- History of malignant neoplasm in the past five years
- Severe infection requiring hospitalization or intravenous antimicrobial therapy
- Use of treatments not permitted by protocol
- Hematological parameters not meeting inclusion criteria
- History of substance abuse or positive substance abuse screening
- Inability to undergo MRI scans
- Pregnant or lactating women
- Other factors deemed unsuitable for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to Day 169
Participants receive multiple ascending doses of 9MW3011 or placebo via intravenous infusion as per protocol to assess safety and tolerability.
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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