Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07463196
PHASE1

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

Sponsor: AC Immune SA

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-01-28

Completion Date

2026-08

Last Updated

2026-03-11

Healthy Volunteers

Yes

Interventions

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

Locations (1)

ICON

Groningen, Netherlands