A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis.

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd

About this trial

The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.

Eligibility criteria

Qualifiers

Sign informed consent form;

Subjects with generalized myasthenia gravis;

Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;

MG-ADL ≥5 at screening and baseline;

Disqualifiers

Subjects with MGFA I and V type;

Subjects usingprescribed drugs;

Subjects with a prescribed disease or history of disease;

The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;

Trial design

Treatments tested in this trial

  • B007
  • Placebo

Treatment groups

104 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Jiaolian Drug Research and Development Co., Ltd

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Collaborator