A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.

Generalized Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447597
• Other study ID #: SPH-B007-303
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 30, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Shanghai Jiaolian Drug Research and Development Co., Ltd
• Contact: Jianying Xi
• Phone: 0086-021-52888045
• Email: hsyybwc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Generalized Myasthenia Gravis
• Myasthenia Gravis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha
China	Huashan Hospital, Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiaolian Drug Research and Development Co., Ltd	Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects:MG-ADL(Myasthenia gravis-activities of daily living profile) decreased by =2	Proportion of subjects:MG-ADL decreased by =2	Approximately 16 weeks
Secondary	Proportion of subjects:subjects without SoC(Standard of Care) change and MG-ADL decreased by =2	Proportion of subjects:subjects without SoC change and MG-ADL decreased by =2	Approximately 24 weeks
Secondary	Proportion of subjects:subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by =3	Proportion of subjects:subjects without SoC change and QMG decreased by =3	Approximately 24 weeks
Secondary	Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline.	Changes in MGQoL15r from baseline.	Approximately 24 weeks
Secondary	Changes in MGC (Myasthenia gravis composite) from baseline.	Changes in MGC from baseline	Approximately 24 weeks
Secondary	Incidence of Treatment-Emergent Adverse Events	Adverse event type, incidence, duration	Approximately 1 years