Monoclonal antibody drug for systemic myasthenia gravis (Tangdu Hospital)

▎ WuXi AppTec content team editor

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Background information

Tangdu Hospital is conducting a clinical study of "a multicenter, randomized, double-blind, placebo-controlled, phase 2/3 operational seamless/group sequential design study evaluating the effectiveness and safety of HBM9161 (HL161) subcutaneous injection in patients with systemic myasthenia gravis", which has been approved by the Hospital Ethics Committee.

The research drug HBM9161 (HL161BKN) injection is an anti-FcRn fully human monoclonal antibody, which is not yet on the market, and is a global new biological product with complete intellectual property rights introduced by the sponsor and Platinum Pharmaceutical, and has been approved by the State Drug Administration to carry out clinical trials. Approximately 144 participants with systemic myasthenia gravis who met the requirements for the study were enrolled in this study.

Selection Criteria

Recruitment conditions:

1. Voluntarily sign a written informed consent form;

2. Male or female ≥ 18 years of age;

3. Conform to the mgFA clinical classification of myasthenia gravis IIa-IVa (including IIa, IIb, IIIa, IIIb and IVa types);

4.Women and men with fertility need to use effective contraception throughout the study period from the signing of the informed consent form and within 14 days after the final visit;

5. Willing to complete all visiting assessments at the research center in accordance with the requirements of the pilot program.

The above are only some of the selection criteria, if you need more information, please contact the research doctor to communicate. Whether you meet the requirements of the study will need to be judged by a series of examinations, which shall be subject to the judgment of the research doctor.

Research Center