A phase I, randomized, investigator/participant blind, parallel-group, placebo-controlled, single and multiple ascending dose study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7504109 in healthy participants

F. Hoffmann-La Roche Ltd0 个研究点目标入组 128 人开始时间: 2024年5月17日最近更新: 2024年5月27日

适应症

试验速览

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•1. Healthy participants with body mass index (BMI) of 18 to 32 kilograms per metre squared (kg/m2) inclusive and a body weight of =50 kg at Screening.
•2. Female participants of childbearing potential (POCBP) are eligible to participate if not pregnant, not breastfeeding, and agree to remain abstinent (refrain from heterosexual intercourse) or use at least one highly effective contraceptive method during the treatment period.
•3. Male Participants must, during the treatment period at least 90 days after the last dose of study treatment, agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures.
•4. Participants who are overtly healthy determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), or vital signs.

•1. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease (including stable asthma and childhood asthma), metabolic disorder, cancer, or cirrhosis.
•2. History of tuberculosis or a positive QuantiFERON Gold test.
•3. Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drugs of abuse.
•4. Positive test (positive antibody or antigen confirmed with positive PCR) result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficient virus (HIV) 1 and 2.
•5. Positive test result (positive immunoglobulin [Ig]G and IgM) for cytomegalovirus or Epstein-Barr virus unless documented resolution of the disease.

发起方