RecruitingPhase 1NCT07463196

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

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 and in Participants With Cardiovascular Risk Factors


Sponsor

AC Immune SA

Enrollment

114 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The main purposes of this study are: * to investigate the safety and tolerability of ACI-19764 when it is administered to healthy participants and participants with cardiovascular risk factors * 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 3 parts, Part A (SAD, single ascending dose) and Part B (MAD, multiple ascending doses) in healthy participants, and Part C (one multiple-dose level) in participants with cardiovascular risk factors. Participants in Part A will receive the study compound once, and participants in Part B and Part C will receive the study compound multiple times (daily over 14 and 28 days, respectively). Parts A and B will be divided into different groups of participants to test different doses of ACI-19764.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ACI-19764 at dose A1, a drug called ACI-19764 at dose A2, and others for people with healthy participants. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Placebo capsules matching ACI-19764 capsules

DRUGACI-19764 at dose A1

ACI-19764 capsules at dose A1

DRUGACI-19764 at dose A2

ACI-19764 capsules at dose A2

DRUGACI-19764 at dose A3

ACI-19764 capsules at dose A3

DRUGACI-19764 at dose A4

ACI-19764 capsules at dose A4

DRUGACI-19764 at dose A5

ACI-19764 capsules at dose A5

DRUGACI-19764 at dose A6

ACI-19764 capsules at dose A6

DRUGACI-19764 at dose B1

ACI-19764 capsules at dose B1

DRUGACI-19764 at dose B2

ACI-19764 capsules at dose B2

DRUGACI-19764 at dose B3

ACI-19764 capsules at dose B3

DRUGACI-19764 at dose C1

ACI-19764 capsules at dose C1


Locations(1)

ICON

Groningen, Netherlands

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NCT07463196


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