NCT06772766RecruitingPhase 1
A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia
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
Source: ClinicalTrials.gov · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 .
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- 30 Dec 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Diseases
- Thalassaemia
- NCT number
- NCT06772766
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 30 Dec 2024 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hainan General Hospital Coordinator of this site? Confirm its status | Haikou | China | Recruiting |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.