CClinicalTrials.gg
Sign In
RecruitingNCT06772766Updated Jan 14, 2025

A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia

A Phase 1 interventional study of 9MW3011 and 9MW3011 placebo in Beta-Thalassemia, sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Mabwell (Shanghai) Bioscience Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 .

Read the detailed description

A total of 40 subjects diagnosed with non-transfusion-dependent β-thalassemia will be enrolled in this study and assigned into four dosage cohorts. In each cohort, subjects will be randomized in a 4:1 ratio to receive 9MW3011 or placebo via intravenous infusion.

02

Conditions studied

  • Beta-Thalassemia
03

In context

Thalassemia

416 studies on the registry are indexed under Thalassemia; 67 are open to participants now.

This study's planned enrollment of 40 is close to the median of 37 across 277 interventional studies indexed under Thalassemia.

Browse Thalassemia studies →

Lead sponsor

Mabwell (Shanghai) Bioscience Co., Ltd. is the lead sponsor of 53 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Male and female subjects aged 18 to 65 years (inclusive)
  2. Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia
  3. Subjects must meet the criteria for non-transfusion-dependent thalassemia
  4. 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
  5. Subjects must have evidence of iron overload during screening
  6. Subject must have performance status: Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
  7. Subjects must fully understand the study procedures and methods, voluntarily participate in the trial, and sign an informed consent form

Key Exclusion Criteria:

  1. Subjects diagnosed with alpha-thalassemia
  2. Subjects diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
  3. Subjects exhibit severe iron overload at the time of screening
  4. 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
  5. Combined with any significant systemic diseases or psychiatric disorders
  6. 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
  7. 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
  8. Uncontrolled hypertension before screening
  9. A history of malignant neoplasm occurring within the last five years
  10. Severe infection requiring hospitalization or intravenous antimicrobial therapy, or uncontrolled systemic bacterial, fungal, or viral active infection
  11. Subject have received concomitant treatment that was not permitted by the protocol
  12. Subjects whose hematological parameters did not meet the inclusion criteria during screening
  13. Subjects with a history of substance abuse, as well as those who yield positive results on substance abuse screening
  14. Subjects who are unable to undergo MRI scans
  15. Pregnant or lactating women
  16. Subjects presenting any other factors deemed unsuitable for participation assessed by the investigator
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Cohort 1

    9MW3011 or placebo (Randomized 4:1)

    Drug: 9MW3011 · Drug: 9MW3011 placebo

  • Experimental
    Cohort 2

    9MW3011 or placebo (Randomized 4:1)

    Drug: 9MW3011 · Drug: 9MW3011 placebo

  • Experimental
    Cohort 3

    9MW3011 or placebo (Randomized 4:1)

    Drug: 9MW3011 · Drug: 9MW3011 placebo

  • Experimental
    Cohort 4

    9MW3011 or placebo (Randomized 4:1)

    Drug: 9MW3011 · Drug: 9MW3011 placebo

Interventions

  • Drug9MW3011

    Ascending IV doses administered per protocol

  • Drug9MW3011 placebo

    Ascending IV doses administered per protocol

06

What researchers measure

Primary outcomes

  1. Adverse Event(including serious adverse event)

    The incidence of Adverse Events(AEs)and Serious Adverse Events(SAEs)from treatment until the last scheduled follow-up visit

    Time frame: up to day 169

  2. Number of subjects with abnormal vital signs

    Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.

    Time frame: up to day 169

  3. Number of subjects with abnormal clinically significant results from physical examination

    The physical examinations will include examination of the following: skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, musculoskeletal, nervous system, and other sites of note elicited from the subject.

    Time frame: up to day 169

  4. Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters

    The examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF(corrected by Fridericia formula).

    Time frame: up to day 169

  5. Number of subjects with abnormal clinically significant clinical laboratory results

    Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.

    Time frame: up to day 169

Secondary outcomes

  1. Concentration of 9MW3011 in serum

    Time frame: up to day 169

  2. PD-parameters-hepcidin

    Change from baseline in hepcidin levels

    Time frame: up to day 169

  3. PD-parameters-serum iron

    Change from baseline in serum iron levels

    Time frame: up to day 169

  4. Anti-drug antibody(ADA)

    The incidence of ADA

    Time frame: up to day 169

  5. Liver iron concentration(LIC)

    Change from baseline in LIC

    Time frame: up to day 169

07

Study locations

2 of 2 sites recruiting
  • The first Affiliated Hospital of Guangxi Medical University
    Nanning, Guangxi 530021, China
    Recruiting
  • Hainan General Hospital
    Haikou, Hainan 570311, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06772766
Lead sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
Responsible party
Sponsor
First posted
Jan 14, 2025
Start date
Dec 30, 2024
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jan 14, 2025

Study contacts

Yongrong Lai
Contact
laiyongrong@hotmail.com
+8607715356304

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Thalassemia→

Other studies from this sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Start the discussion