health Subjects
Conditions
Interventions
Arm 1:200 mg Sibeprenlimab (1 × 1 mL injection)
Arm 2:400 mg Sibeprenlimab (1 × 2 mL injection)
Arm 3:600 mg Sibeprenlimab (1 × 1 mL injection and 1 × 2 mL injection)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Subjects are required to meet the following inclusion criteria when assessed: 1. Chinese subject between 18 and 55 years of age, inclusive, at the screening visit. 2. Healthy, as determined by pretrial medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram [ECG], and clinical laboratory evaluations), as judged by the investigator. 3. Body mass index between 19 and 32 kg/m2, inclusive, and body weight not less than 50 kg at the screening visit. 4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 5. Screening clinical laboratory test values for IgA, IgG, and IgM must meet the following criteria (the clinical laboratory tests may be repeated once per the discretion of the investigator): 1) Serum IgA: >= 0.8 g/L 2) Serum IgG: >= 7.0 g/L 3) Serum IgM: >= 0.4 g/L
Exclusion criteria
Exclusion criteria: Subjects will be excluded if they meet any of the following exclusion criteria when assessed: 1. Subjects with potential to contribute to pregnancy who do not agree to practice 2 different approved methods of birth control or remain fully abstinent (periodic abstinence [eg, calendar, ovulation, symptothermal, post ovulation methods] or withdrawal are not acceptable methods of contraception) from the time of consent through the end of the subjects participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter. If employing birth control, 2 of the following methods must be used: vasectomy, tubal ligation, intrauterine device, birth control pill, birth control implant, birth control depot injection, birth control patch, condom with spermicide, sponge with spermicide, or occlusive cap (vaginal diaphragm or cervical/vault cap) with spermicide. 2. Subjects must also agree not to donate sperm from the time of consent through the end of the subjects participation in the trial and an additional 90 days thereafter. 3. Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary. 4. History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis. 5. Known hypoglobulinemia disorder (ie, common variable immunodeficiency), X-linked agammaglobulinemia, selective IgA deficiency, selective IgM deficiency). 6. History of chronic infection (eg, tuberculosis, osteomyelitis, etc) or any infection requiring hospitalization or treatment with antivirals, antibiotics, or antifungal therapy within 30 days prior to administration of IMP. 7. Received vaccination during the 30 days prior to administration of IMP. 8. Known hepatic (ie, prior or chronic hepatitis C or hepatitis B infection, nonalcoholic steatohepatitis, or cirrhosis) or biliary abnormalities (Gilberts syndrome or asymptomatic gallstones are permitted exceptions). 9. A QT interval corrected for heart rate using Fridericias correction (QTcF) > 450 msec for biological male subjects or > 470 msec for biological female subjects (may be repeated once). 10. Previous receipt of antibody or biologic therapy whether licensed or investigational (Ig products, monoclonal antibodies, or antibody fragments) within 30 days prior to dosing or 5 half-lives within the dose of IMP, whichever is longer. 11. Concomitant use of marketed or investigational systemic immunosuppressive or immunomodulatory medications (eg, corticosteroids, methotrexate, azathioprine, etc. and/or biologics) is prohibited and require a washout period prior to screening (30 days or 5 half-lives, whichever is longer). 12. Has received any prescription or nonprescription (over-the-counter [OTC]) medication during the last 30 days or 5 half-lives (of the drug in question), whichever is longer, preceding baseline (Day 1), with the exception of acetaminophen, ibuprofen (or an equivalent nonsteroidal anti-inflammatory drug), hormonal contraceptives, topical medications, vitamins, minerals, traditional Chinese medicines, and dietary or erbal remedies. 13. Is participating in another clinical trial of any inve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactPing Feng
West China Hospital, Sichuan University
Outcome results
None listed