Tests 9MW3011 in adults with non-transfusion-dependent beta-thalassemia
Tests the drug 9MW3011, against a placebo, in adults with beta-thalassemia.
Plain-language title generated from the registry record
Registry title: A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia
Key facts
- Where
- Haikou and Nanning, ChinaSee the 2 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06772766, who can take part
Where in China
- Hainan General HospitalHaikou, ChinaTaking people
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Trial code
- NCT06772766
- Record updated
- 14 January 2025
- Original description
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 .Read full original descriptionShow less
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 β- Thalassemia
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 .
Inclusion: 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: 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; Subject have received concomitant treatment that was not permitted by the protocol; 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; Uncontrolled hypertension before screening; A history of malignant neoplasm occurring within the last five years; Severe infection requiring hospitalization or intravenous antimicrobial therapy, or uncontrolled systemic bacterial, fungal, or viral active infection; Subjects with a history of substance abuse, as well as those who yield positive results on substance abuse screening; 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; 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; Subjects whose hematological parameters did not meet the inclusion criteria during screening; Subjects who are unable to undergo MRI scans; Pregnant or lactating women; Subjects presenting any other factors deemed unsuitable for participation assessed by the investigator.