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

NCT07463196 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Healthy Participants

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

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • AC Immune SA

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · ICON plc

  • Clinical Lead · AC Immune SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463196 on ClinicalTrials.gov