A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients

• Status: Completed
• Trial end date: 2021-08-24
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objectives: To investigate the efficacy of HBM9161 in patients with attack of MG in China

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harbour BioMed (Guangzhou) Co. Ltd.

Criteria

Inclusion Criteria:

1. Signed Informed Consent Form.

2. Male or female ≥ 18 years of age.

3. A female participant is eligible to participate if she is of:

1. Non-childbearing potential (physically infertile, including women who have been menopausal for 2 years or more);

2. Childbearing potential, negative serum pregnancy test results at screening visits, and agree to consistently use acceptable and effective contraceptive methods until 14 days after the final visit.

4. A male participant must take effective contraception during this clinical trial or their heterosexual partner must take effective contraception.

5. Positive serologic test for AChR-Ab or MUSK-Ab at the screening visit and at least 1 of the following:

1. History of abnormal neuromuscular transmission test demonstrated by sign-fiber-electromyography or repetitive nerve stimulation OR

2. History of positive edrophonium chloride test OR

3. Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician.

Exclusion Criteria:

1. Use of rituximab, belimumab, eculizumab or any monoclonal antibody/Fc-fusion biologic for immunomodulation within 6 months prior to screening.

2. Immunoglobulins given by SC, IV(IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before screening.

3. Thymectomy performed < 12 months prior to screening.

4. Total IgG level <6g/L (at screening).

5. Participant has any laboratory abnormality (at screening) that, in the opinion of the investigator, is clinically significant, has not resolved at baseline, and could jeopardize or would compromise the participant's ability to participate in this study.

6. Have known autoimmune disease other than MG that would interfere with the course and conduct of the study (such as uncontrolled thyroid disease).

7. Have an active infection, a recent serious infection (i.e., requiring injectable antimicrobial therapy or hospitalization) within the 8 weeks prior to screening.

8. History of or known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Participants must have negative test results for HBV surface antigen, HBV core antibody, HCV antibody, HIV 1 and 2 antibodies and a negative TB test at screening.