Actively Recruiting
A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants
Led by AC Immune SA · Updated on 2026-03-11
78
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
AC Immune SA
Lead Sponsor
I
ICON Clinical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- Healthy males (all parts) or females (Part B only) aged 18 to 65 years (inclusive) at screening.
- Body mass index between 18.0 and 29.9 kg/m2 (inclusive) at screening.
- Ability to communicate well with the investigator and comply with study requirements.
- Systolic blood pressure 90-140 mmHg, diastolic blood pressure 45-90 mmHg, and pulse rate 40-100 bpm measured after 5 minutes lying down at screening and admission.
- 12-lead ECG with QTcF <450 ms for males, <470 ms for females, QRS interval <120 ms, PR interval <220 ms, heart rate 40-100 bpm, and no clinically relevant abnormalities at screening and admission.
- Fertile males must agree to abstain from fathering a child or use condoms with women of childbearing potential from first treatment until 90 days after last treatment and advise partners to use effective contraception.
- Part B females must have negative pregnancy tests, FSH test at screening, and agree to use highly effective contraception or be sexually inactive or have a vasectomized partner during the study and for 30 days after last treatment.
- Part B females who are not of childbearing potential must be postmenopausal or have documented surgical sterilization or certain medical conditions as specified.
You will not qualify if you...
- Known allergy or hypersensitivity to ACI-19764 components or related substances.
- Allergies to NSAIDs, NLRP3 inhibitors, vaccines, cosmetics, latex, or certain foods.
- Clinically relevant physical exam findings or laboratory abnormalities at screening or Day -1.
- History or presence of heart rhythm disorders, congestive heart failure, or structural heart disease.
- History of surgical procedures that could affect drug safety or metabolism.
- Acute, ongoing, recurrent, or chronic diseases that could interfere with safety or drug metabolism.
- Acute or chronic lung diseases including COPD, asthma, or recurrent lung infections.
- History of suicide attempt or recent suicidal ideation.
- Cancer within the past 5 years except certain fully treated skin or in situ cancers.
- History of unexplained fainting or syncope that could affect safety assessment.
- Veins unsuitable for intravenous access on both arms.
- Participation in another clinical trial with drug treatment within 3 months or more than 3 trials in past year.
- History or evidence of alcoholism or drug abuse in past 3 years.
- Excessive alcohol consumption (>14 units/week females, >21 units/week males).
- Excessive caffeine or nicotine use recently.
- Significant blood loss or donation recently.
- Positive drug, alcohol, hepatitis B/C, or HIV tests at screening.
- Conditions affecting full study participation or compliance.
- Legal incapacity or limited legal capacity.
- Recent use of prescribed medications or immunosuppressive therapies except allowed contraceptives.
- Recent vaccines or infections, active tuberculosis or recent exposure.
- Planned hospitalization or surgery during the study.
- Part A food effect cohort: inability or unwillingness to consume high-fat breakfast.
- Part B: pregnant or lactating women.
- Part B lumbar puncture contraindications or relevant back pain or recurrent headaches history.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
ICON
Groningen, Netherlands, 9728 NZ
Actively Recruiting
Research Team
A
AC Immune Clinical Lead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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