Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT06772766

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

Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-01-14

40

Participants Needed

2

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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 70-100 g/L based on two 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
  • Understand study procedures, voluntarily participate, and sign informed consent
Not Eligible

You will not qualify if you...

  • Diagnosed with alpha-thalassemia
  • Diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
  • Severe iron overload at screening
  • Other forms of anemia or hematological disorders that may affect safety or study outcomes
  • Significant systemic diseases or psychiatric disorders
  • New York Heart Association (NYHA) Class III-IV heart failure or other cardiovascular diseases within 6 months prior to screening or currently present
  • QTcF interval ≥450ms for males or ≥470ms for females on 12-lead ECG or clinically significant abnormal ECG
  • Uncontrolled hypertension before screening
  • History of malignant neoplasm within the last 5 years
  • Severe infection requiring hospitalization or intravenous antimicrobial therapy or uncontrolled systemic infection
  • Received treatment not permitted by protocol
  • Hematological parameters not meeting inclusion criteria during screening
  • History of substance abuse or positive substance abuse screening
  • Unable to undergo MRI scans
  • Pregnant or lactating women
  • Other factors deemed unsuitable by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

Y

Yongrong Lai

CONTACT

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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