A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia (NCT06772766) | Clinical Trial Compass
RecruitingPhase 1
A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia
China40 participantsStarted 2024-12-30
Plain-language 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 .
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male and female subjects aged 18 to 65 years (inclusive)
✓. Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia
✓. Subjects must meet the criteria for non-transfusion-dependent thalassemia
✓. Subjects must have a baseline hemoglobin level between 70-100 g/L(inclusive), based on 2 consecutive measurements taken at least 1 week apart within 4 weeks before randomization
✓. Subjects must have evidence of iron overload during screening
✓. Subject must have performance status: Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
✓. Subjects must fully understand the study procedures and methods, voluntarily participate in the trial, and sign an informed consent form
Exclusion criteria
✕. Subjects diagnosed with alpha-thalassemia
✕. Subjects diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
✕. Subjects exhibit severe iron overload at the time of screening
✕. In addition to thalassemia, subjects have any other forms of anemia and hematological disorders that the investigator assesses may compromise safety or influence study outcomes
✕. Combined with any significant systemic diseases or psychiatric disorders
What they're measuring
1
Adverse Event(including serious adverse event)
Timeframe: up to day 169
2
Number of subjects with abnormal vital signs
Timeframe: up to day 169
3
Number of subjects with abnormal clinically significant results from physical examination
Timeframe: up to day 169
4
Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Timeframe: up to day 169
5
Number of subjects with abnormal clinically significant clinical laboratory results
✕. Subjects have New York Heart Association (NYHA) Class III-IV heart failure and other cardiovascular diseases within 6 months prior to screening or currently present
✕. During the screening or baseline period, subjects exhibiting a QTcF interval of ≥450ms for males and ≥470ms for females on a 12-lead electrocardiogram (ECG), or presenting an abnormal 12-lead ECG with clinical significance