NCT07463196

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: AC Immune SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

In study Part A (SAD part), up to 6 dose levels with 8 male participants in each are planned (6 participants on ACI-19764 and 2 on placebo). Each cohort has a screening period followed by admission to the site for administration of ACI-19764. Participants remain onsite for observation for 3 days. Participants may need to return for additional visits for 2 days after discharge to check the blood levels of the drug. A safety follow up call is planned approximately 3 weeks after discharge. In one of the higher dose cohorts, the effect of food on drug levels in the blood will also be explored with an additional admission. There may be fewer than 6 cohorts. In study Part B (MAD part), up to 3 dose levels with 10 participants (8 on active and 2 on placebo) in each are planned. Each dose level will be investigated in a separate cohort of 10 healthy male and female participants (with 4 participants of each sex on active treatment and 1 of each sex on placebo). Each cohort has a screening period followed by admission to the site for 17 days (14-day treatment and 3 days observation). Depending on the blood levels of the drug, participants may have to return to the site for additional blood tests for the 2 days following discharge. A safety phone call is planned approximately 3 weeks after discharge.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Placebo	Placebo capsules matching ACI-19764 capsules
DRUG	ACI-19764 at dose A1	ACI-19764 capsules at dose A1
DRUG	ACI-19764 at dose A2	ACI-19764 capsules at dose A2
DRUG	ACI-19764 at dose A3	ACI-19764 capsules at dose A3
DRUG	ACI-19764 at dose A4	ACI-19764 capsules at dose A4
DRUG	ACI-19764 at dose A5	ACI-19764 capsules at dose A5
DRUG	ACI-19764 at dose A6	ACI-19764 capsules at dose A6
DRUG	ACI-19764 at dose B1	ACI-19764 capsules at dose B1
DRUG	ACI-19764 at dose B2	ACI-19764 capsules at dose B2
DRUG	ACI-19764 at dose B3	ACI-19764 capsules at dose B3

Timeline

• Start date: 2026-01-28
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: Netherlands