Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject (NCT07105124) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject
China24 participantsStarted 2022-10-18
Plain-language summary
A Trial to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics, of Sibeprenlimab Solution Administered Subcutaneously in Chinese Healthy Subjects
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Chinese subject between 18 and 55 years of age, inclusive, at the screening visit.
* Healthy, as determined by pretrial medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram \[ECG\], and clinical aboratory evaluations), as judged by the investigator.
* Body mass index between 19 and 32 kg/m2, inclusive, and body weight not less than 50 kg at the screening visit.
* 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.
* 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):
* Serum IgA: ≥ 0.8 g/L
* Serum IgG: ≥ 7.0 g/L
* Serum IgM: ≥ 0.4 g/L
Exclusion Criteria:
* 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 subject's 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 devic…
What they're measuring
1
Sibeprenlimab serum concentrations
Timeframe: Day 1 (predose, 4 hours postdose, and 8 hours postdose) and on Day 2 (24 hours postdose). All subjects will also have blood samples collected for PK analysis on Days 3, 5, 7, 9, 14 (Week 2), 28 (Week 4), 42 (Week 6), 56 (Week 8), 70 (Week 10), and 84