Clinical Trial

A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants

Recruiting Phase 1
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Summary
The main purposes of this study are: * to investigate the safety and tolerability of ACI-19764 when it is administered to healthy participants * to determine how quickly and to what extent ACI-19764 is absorbed, transported, metabolized, and excreted by the body (fasted and after a meal) * to determine the effect of ACI-19764 on specific markers in the blood that are part of the immune system The effects of ACI-19764 will be compared with the effects of a placebo. ACI-19764 is a brain-penetrant NLRP3 inhibitor. The study consists of 2 parts, Part A (SAD, single ascending dose) and Part B (MAD, multiple ascending doses). Participants in Part A will receive the study compound once and participants in Part B will receive the study compound multiple times (daily over 14 days). Each of these 2 study parts will be divided into different groups of participants to test different doses of ACI-19764.
Trial Details
NCT Number NCT07463196
Lead Sponsor AC Immune SA
Collaborators: ICON Clinical Research
Conditions Healthy Participants
Enrollment 78 participants
Start Date 2026-01-28
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-11