Healthy Volunteers Clinical Trial
Official title:
A Randomized, Sponsor-Open, Adaptive, Single- And Multiple-Ascending Dose, Placebo-Controlled Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of RO7223280 Following Intravenous Administration In Healthy Participants
The Study consists of 3 Parts: Part 1 (Single Ascending Dose/SAD), Part 2 (Multiple Ascending Dose/MAD), and Part 3 (Elderly). Part 1 will investigate the safety, tolerability and PK of single-ascending intravenous (IV) doses of RO7223280 in healthy participants. Part 2 will investigate the safety, tolerability and PK of multiple-ascending IV doses of RO7223280 in healthy participants. Part 2 will start after the initial completion of Part 1 (SAD). Progression from Part 1 to Part 2 will be based on a satisfactory review of all available safety, tolerability, and PK data by the Investigator and the Sponsor from Part 1. The starting dose for Part 2 will be administered as 1-hour IV infusion; as it has been established on the basis of all available safety, tolerability, and PK data in Part 1 (SAD). Part 3 will investigate the safety, tolerability and PK of a single IV dose of RO7223280 in healthy elderly participants. A single IV dose of RO7223280 administered over 1 hour was selected, within the range of previously explored doses in Part 1 (SAD).
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