A Phase I, open-label, parallel-group study to investigate the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single subcutaneous administration of RO7434656 in healthy adult Chinese participants

F. Hoffmann-La Roche Ltd0 个研究点目标入组 14 人开始时间: 2024年8月23日最近更新: 2024年9月2日

适应症

试验速览

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•1. Overtly healthy and has no evidence of active or chronic disease as determined by detailed medical and surgical history and the results of a physical examination, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests.
•2. Body weight greater than or equal to 50 kilograms (kg) and a body mass index within the range 18.5 to 28.0 kilogram per meter squared (kg/m2)
•3. Vaccination against Neisseria meningitidis within 5 years prior to initiation of study treatment
•4. Vaccination against Streptococcus pneumoniae within 5 years prior to initiation of study treatment

•1. Treatment with any other investigational drug, biological agent, or device within 4 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment.
•2. Received or is scheduled to receive any live vaccine within 4 weeks prior to the first dose of investigational product or within 90 days after receipt of the investigational product.
•3. Received or is scheduled to receive an inactivated vaccine within 1 week prior to the first dose of investigational product or within 90 days after receipt of the investigational product.
•4. History or evidence of any medical conditions (e.g., gallbladder removal, malabsorption syndrome, or hepatic disorder) potentially altering the absorption, distribution, metabolism, or elimination of drugs.
•5. Social circumstances that increase the risk of infection with bacteria that can cause encapsulated infections
•6. History or presence of clinically significant cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, pulmonary disease, or history of any of these diseases with renal, hepatic, or cardiopulmonary dysfunction.
•8. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the single SC dose of RO7434656.

发起方