Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

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

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 in Subjects With Generalized Myasthenia Gravis

A Clinical Study of B007 in the Treatment of Generalized Myasthenia Gravis. (NCT06447597) is a Phase 2 / Phase 3 interventional studying Generalized Myasthenia Gravis, sponsored by Shanghai Jiaolian Drug Research and Development Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Generalized Myasthenia Gravis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 104 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Generalized Myasthenia Gravis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Sign willing to sign a consent form 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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 willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

B007

B007 high dose and low dose： Subcutaneous injection was administered on days 1 and 15

DRUG

Placebo

B007 matched Placebo Subcutaneous injection was administered on days 1 and 15

Locations (18)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking University First Hospital

Beijing, China

The First Bethune Hospital of Jilin University

Changchun, China

Xiangya Hospital Central South University

Changsha, China

Sichuan Provincial People's Hospital

Chengdu, China

Nanfang Hospital, Southern Medical University

Guangzhou, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Shandong Provincial Qianfoshan Hospital

Jinan, China

Shandong University Cheeloo College of Medicine

Jinan, China

First People's Hospital of Yunnan Province

Kunming, China

Jiangxi Provincial People's Hospital

Nanchang, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

Shandong University Cheeloo College of Medicine

Qingdao, China

Huashan Hospital, Fudan University

Shanghai, China

Shenzhen Hospital of University of Hong Kong

Shenzhen, China

Renmin Hospital of Wuhan University

Wuhan, China

Tongji Medical College of HUST

Wuhan, China

Tangdu Hospital

Xi'an, China

Affiliated Hospital of Zunyi Medical College

Zunyi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06447597), the sponsor (Shanghai Jiaolian Drug Research and Development Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06447597 clinical trial studying?

The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06447597?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06447597?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06447597. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06447597. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.