Clinical trial • Phase I • Neurology

ACI-19764 for Healthy volunteers

Phase I trial of ACI-19764 for Healthy volunteers. Randomised, placebo (dose and schedule not specified)-controlled. 78 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Healthy volunteers
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
17-11-2025
First CTIS Authorization Date
13-01-2026

Trial design

Randomised, placebo (dose and schedule not specified)-controlled Phase I trial across 1 site in Netherlands.

Randomised
Yes
Comparator
Placebo (dose and schedule not specified)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
78
Trial Duration For Participant
212

Eligibility

Recruits 78 Vulnerable population selected; no details provided on consent or assent handling..

Vulnerable Population
Vulnerable population selected; no details provided on consent or assent handling.

Recruitment

Planned Sample Size
78
Recruitment Window Months
7

Geography

Total Number Of Sites
1
Total Number Of Participants
78

Netherlands

Earliest CTIS Part Ii Submission Date
09-01-2026
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
4
Number Of Sites
1
Number Of Participants
78

Sites

Site Name
Pharmaceutical Research Associates Group B.V.
Department Name
Program Management
Contact Person Name
Renger Tiessen
Contact Person Email
Renger.Tiessen@iconplc.com
Number Of Participants
78

Sponsor

Primary sponsor

Full Name
AC Immune S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
ACI-19764

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