study of efavaleukin alfa in healthy chinese, japanese, and caucasian participants

Conditions: Inflammatory Diseases

Summary: the primary objective of this study is to evaluate the pharmacokinetics (pk) of efavaleukin alfa after single subcutaneous (sc) administration in healthy chinese, japanese, and caucasian participants.


Eligibility criteria:
inclusion criteria: * healthy male or female participants, between 18 and 55 years of age (inclusive) at the time of screening. * chinese, japanese, or caucasian participant: * chinese participants must be of chinese ancestry (4 grandparents and biological parents). * japanese participants must be first- or second-generation japanese (4 grandparents and biological parents; participant or both of their parents must have been born in japan). * caucasian participants are those who self-identify exclusively as such on the electronic case report form (ecrf) and also identify their biological parents as such. * in good health, determined by no clinically significant findings from medical history, physical examinations, 12-lead electrocardiogram (ecg), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of gilbert's syndrome based on total and direct bilirubin\] is not acceptable) as assessed by the investigator (or designee). * body mass index between 17 and 30 kg/m\^2 (inclusive) at the time of screening. exclusion criteria: * evidence of scars, tattoos, or other skin lesions that may interfere with the injection site or injection site assessments. * history or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ecg taken at check-in. * a qt interval corrected for heart rate using fridericia's method (qtcf) interval \> 450 msec in male participants or \> 470 msec in female participants or history/evidence of long qt syndrome, at screening or check-in. * pr interval \> 210 msec, at screening or check-in. * second- or third-degree atrioventricular (av) block , at screening or check-in. * systolic blood pressure (bp) \> 140 mmhg or \ 90 mmhg, or hr \> 100 bpm, at screening or check-in. * estimated glomerular filtration rate less than 60 ml/min/1.73 m\^2 as calculated by the modification of diet in renal disease equation, at screening. * hba1c ≥ 7%, at screening or check-in. * participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines within 105 days after administration of an investigational product. * positive hepatitis b or hepatitis c panel (ie, positive hepatitis b surface antigen, hepatitis b core antibody or hepatitis c antibody) at screening, or a medical history for hepatitis b or c; and/or positive human immunodeficiency virus test, at screening. participants whose results are compatible with prior vaccination may be included. participants with a history of hepatitis b vaccination without a history of hepatitis b or c are allowed to participate. * consumption of foods and beverages containing poppy seeds within 7 days prior to check-in. * history of alcoholism or drug/chemical abuse within 1 year prior to check-in. * use of tobacco- or nicotine-containing products within 6 months prior to check-in. * positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at screening or check-in. * female participants with a positive pregnancy test at screening or check-in. * participant has received a dose of an investigational drug within the past 90 days or 5 half-lives of the drug, whichever is longer, prior to check-in. * donation of blood from 90 days prior to check-in, plasma from 2 weeks prior to check-in, or platelets from 6 weeks prior to check-in. * participants with abnormal laboratory results for alanine aminotransferase (alt) or aspartate aminotransferase (ast) (ie, \> upper limit of normal) and total bilirubin (ie, \> upper limit of normal) at screening and check-in.

Keywords: systemic lupus erythematosus (sle) steroid-refractory chronic graft-versus-host disease (gvhd) ulcerative colitis single-dose study efavaleukin alfa regulatory t cells (tregs) inflammatory