A Dose-Escalation Study of RO7875913 in Healthy Participants
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Healthy Volunteers
Спонсор: Genentech, Inc.
Налично на:
БГ
Обобщение
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy participants.
Кой може да участва
Inclusion Criteria:
* Agreement to adhere to the contraception requirements
* Body weight \> 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m\^2)
Exclusion Criteria:
* Positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen
* History of any malignancy
* Major surgical procedure within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
* Known allergy or hypersensitivity to any component of the RO7875913 formulation
* Treatment with investigational biologic therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
* Treatment with investigational non-biologic therapy (or blinded comparator) within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
* Treatment with any immunosuppressive medication within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug