Phase
Condition
Sarcopenia
Polymyositis (Inflammatory Muscle Disease)
Neuropathy
Treatment
B007
Placebo
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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;
Before randomization, subjects received at least one gMG stable dose of SoC, andmaintain a stable dose throughout the test;
Subjects agree to use effective contraceptive methods for contraception from signingthe informed consent form to 1 year after the last dose. Female subjects consideredfertile by the investigator must have negative serum pregnancy tests before thefirst dose.
Exclusion
Exclusion Criteria:
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 asunsuitable for participation in the study by the investigator;
Known history of severe allergic reaction to humanized monoclonal antibodies, orknown allergy to any component of B007;
Subjects who received live vaccine at the specified time before the first dose andare expected to receive the vaccine at the specified time after the last dose;
Subjects who have received major surgery or participated in other clinical trialswithin the prescribed time before screening;
Pregnant and lactating women;
Fertile female subjects do not agree to use effective contraception from signing theinformed consent form to 1 years after the last dose.
Sexually active male subjects who do not intend to use an effective contraceptivemethod during the trial period or within1 years after the last dose, or malesubjects who plan to donate sperm during the trial or within 1 year after the lastdose;
A history of alcohol or drug abuse within the past 12 months;
Other conditions deemed unsuitable for participation in this study by theresearchers.
Study Design
Connect with a study center
Peking University First Hospital
Beijing,
ChinaActive - Recruiting
The First Bethune Hospital of Jilin University
Changchun,
ChinaActive - Recruiting
Xiangya Hospital Central South University
Changsha,
ChinaActive - Recruiting
Sichuan Provincial People's Hospital
Chengdu,
ChinaActive - Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou,
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou,
ChinaActive - Recruiting
Shandong Provincial Qianfoshan Hospital
Jinan,
ChinaActive - Recruiting
Shandong University Cheeloo College of Medicine
Jinan,
ChinaActive - Recruiting
First People's Hospital of Yunnan Province
Kunming,
ChinaActive - Recruiting
Jiangxi Provincial People's Hospital
Nanchang,
ChinaActive - Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang,
ChinaActive - Recruiting
Shandong University Cheeloo College of Medicine
Qingdao,
ChinaActive - Recruiting
Huashan Hospital, Fudan University
Shanghai,
ChinaActive - Recruiting
Shenzhen Hospital of University of Hong Kong
Shenzhen,
ChinaActive - Recruiting
Renmin Hospital of Wuhan University
Wuhan,
ChinaActive - Recruiting
Tongji Medical College of HUST
Wuhan,
ChinaActive - Recruiting
Tangdu Hospital
Xi'an,
ChinaActive - Recruiting
Affiliated Hospital of Zunyi Medical College
Zunyi,
ChinaActive - Recruiting
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