A Single-Center, Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses of ACI-19764 in Healthy Participants

NCT07463196 Phase 1 RECRUITING

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.

Details

Lead sponsor	AC Immune SA
Phase	Phase 1
Status	RECRUITING
Enrolment	78
Start date	2026-01-28
Completion	2026-08

Conditions

• Healthy Participants

Interventions

• Placebo
• ACI-19764 at dose A1
• ACI-19764 at dose A2
• ACI-19764 at dose A3
• ACI-19764 at dose A4
• ACI-19764 at dose A5
• ACI-19764 at dose A6
• ACI-19764 at dose B1
• ACI-19764 at dose B2
• ACI-19764 at dose B3

Primary outcomes

• Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely related, possibly related or probably related) — From first study treatment administration up to the end of the safety follow-up (i.e. 21 to 24 days after Day 4 for study Part A and 21 to 24 days after Day 17 for study Part B)
• Vital signs: Change from baseline in blood pressure — From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
• Vital signs: Change from baseline in respiratory rate — From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
• Vital signs: Change from baseline in pulse rate — From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
• Vital signs: Change from baseline in body temperature — From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
• ECG: Change from baseline in heart rate — From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)

Countries

Netherlands