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Clinical Trials in China / NCT06447597
Recruiting Phase 2/3

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

NCT06447597 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (18)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT06447597 on ClinicalTrials.gov ↗ ← All trials in China