Shanghai Jiaolian Drug Research and Development Co., Ltd
Phase
Phase 2/3
Started
2024-07-01
Last updated
2026-08-14
Condition(s) studied
Generalized Myasthenia Gravis
Investigational drug(s) / intervention(s)
B007Placebo
B007: B007 high dose and low dose: Subcutaneous injection was administered on days 1 and 15
Placebo: B007 matched Placebo Subcutaneous injection was administered on days 1 and 15
Study summary
The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Sign informed consent form;
2. Subjects with generalized myasthenia gravis;
3. Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
4. MG-ADL ≥5 at screening and baseline;
5. Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
6. Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose.
Exclusion Criteria:
1. Subjects with MGFA I and V type;
2. Subjects usingprescribed drugs;
3. Subjects with a prescribed disease or history of disease;
4. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
5. Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
6. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
7. Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
8. Pregnant and lactating women;
9. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
10. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose;
11. A history of alcohol or drug abuse within the past 12 months;
12. Other conditions deemed unsuitable for participation in this study by the researchers.
Primary outcome measure(s)
Proportion of subjects:MG-ADL(Myasthenia gravis-activities of daily living profile) decreased by ≥2 — Approximately 16 weeks Proportion of subjects:MG-ADL decreased by ≥2
Trial sites (18)
Facility
City
Region
Status
Peking University First Hospital
Beijing
China
Recruiting
The First Bethune Hospital of Jilin University
Changchun
China
Recruiting
Xiangya Hospital Central South University
Changsha
China
Recruiting
Sichuan Provincial People's Hospital
Chengdu
China
Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou
China
Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
China
Recruiting
Shandong Provincial Qianfoshan Hospital
Jinan
China
Recruiting
Shandong University Cheeloo College of Medicine
Jinan
China
Recruiting
First People's Hospital of Yunnan Province
Kunming
China
Recruiting
Jiangxi Provincial People's Hospital
Nanchang
China
Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
China
Recruiting
Shandong University Cheeloo College of Medicine
Qingdao
China
Recruiting
Huashan Hospital, Fudan University
Shanghai
China
Recruiting
Shenzhen Hospital of University of Hong Kong
Shenzhen
China
Recruiting
Renmin Hospital of Wuhan University
Wuhan
China
Recruiting
Tongji Medical College of HUST
Wuhan
China
Recruiting
Tangdu Hospital
Xi'an
China
Recruiting
Affiliated Hospital of Zunyi Medical College
Zunyi
China
Recruiting
More Shanghai Jiaolian Drug Research and Development Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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