Healthy ParticipantsPhase 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 Phase 1 study testing ACI-19764 at dose A1, ACI-19764 at dose A2 and ACI-19764 at dose A3 in people with Healthy Participants and Obesity, run by AC Immune SA at 1 site in Netherlands.

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Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants, Obesity, Type 2 Diabetes Mellitus (T2DM)
What is being tested?: ACI-19764 at dose A1, ACI-19764 at dose A2 and ACI-19764 at dose A3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 114 participants
Where: 1 siteNetherlands
Study dates: 28 Jan 2026to Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
Healthy male (Parts A and B) or female (Part B) aged between 18 and 65 years (inclusive) at screening or, male or female with cardiovascular risk factors between 18 and 75 years (inclusive) (Part C).
For Parts A and B: Body mass index of 18.0 to 29.9 kg/m2 (inclusive) at screening.
For Part C: Presence of either obesity (defined as a BMI of 30.0-42.0 kg/m2 inclusive) and/or existing diagnosis of well controlled type II diabetes (with HbA1c >6.5% or 48 mmol/mol and ≤8.5% or 69 mmol/mol) (for participants with diabetes the BMI can range between 18.0-42.0 kg/m2 inclusive).
For Part C: serum CRP >3.0 mg/L and <10.0 mg/L at screening and reconfirmed prior first dosing.
Ability to communicate well with the investigator, and to understand and comply with the study requirements.

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Systolic blood pressure (SBP) 90-140 mmHg, diastolic blood pressure (DBP) 45-90 mmHg, and pulse rate 40 to 100 beats per minute (bpm) (all inclusive), measured on either arm (same arm used for both screening and admission), after 5 min in the supine position at screening and admission. For Part C: SBP may be 90-160 mmHg, and DBP 45-100 mmHg (all inclusive).
12-lead safety ECG: QT interval corrected for HR using Fridericia's formula (QTcF) <450 ms for male participants and <470 ms for female participants, QRS interval <120 ms, PR interval <220 ms, and HR 40 to 100 bpm (inclusive), and without clinically relevant abnormalities, measured after 5 min in the supine position at screening and admission.
For Part C: Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2
Fertile male participants (defined as physiologically capable of conceiving a child according to the investigator's judgment) must agree to refrain from fathering a child and:
Be sexually abstinent with women of childbearing potential (WoCBP) or use condoms during sexual intercourse with WoCBP from (first) study treatment administration up to at least 90 days after (last) study treatment administration. Male participants must advise their WoCBP partners consistently to use a highly effective method of contraception with a failure rate of <1% per year.
Do not donate sperm from (first) study treatment administration up to at least 90 days after (last) study treatment administration.
Parts B and C only: Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission and a follicle-stimulating hormone (FSH) test must be performed at screening. WoCBP must agree to consistently and correctly use (from screening, during the entire study, and for at least 30 days after the last study treatment administration) a highly effective method of contraception with a failure rate of <1% per year, be sexually inactive, or have a vasectomized partner with a post-vasectomy semen analysis negative for sperm at least 6 months before screening. If a hormonal contraceptive is used, it must be initiated at least 1 month before the first study treatment administration and should be used in conjunction with barrier methods. WoCBP must agree to not donate eggs from screening until at least 30 days after the last study treatment administration.
Parts B and C only: WoNCBP must be postmenopausal or have documented previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, uterine agenesis.

Who cannot join

Known hypersensitivity to any excipient of the ACI-19764 formulations.
Known clinically relevant hypersensitivity or allergy to any therapeutic treatment (including non-steroidal anti-inflammatory drugs [NSAIDs], or nucleotide-binding oligomerization domain-like receptor family pyrin domain-containing 3 [NLRP3] inhibitors), vaccines, cosmetics, natural rubber or latex and/or food.
Clinically relevant findings on the physical examination at screening or on Day -1.
Clinically relevant findings in clinical laboratory tests
Clinically relevant history or presence of rhythm disorders, congestive heart failure, or structural heart disease.
History or presence of clinically relevant surgical intervention which, in the opinion of the investigator, could potentially interfere with the safety/tolerability and/or absorption, distribution, metabolism, and excretion (ADME) of the study treatment.

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History or presence of acute, ongoing, recurrent, or chronic clinically relevant diseases which, in the opinion of the investigator, could potentially interfere with the assessment of safety/tolerability and/or ADME of the study treatment. For Part C: obesity, well-controlled type 2 diabetes, well-controlled hypertension, hypercholesterolemia, and osteoarthritis are acceptable co-morbidities.
For Part C: occurrence of diabetic ketoacidosis within the last 3 months
History or current acute or chronic pulmonary pathology including but not limited to chronic obstructive pulmonary disease (COPD), asthma, and recurrent lung infections.
Lifetime history of suicide attempt (including active attempt, interrupted attempt or aborted attempt) or suicidal ideation in the past 6 months according to the C-SSRS at screening (Parts B and C only).
History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma, and melanoma in situ, or in-situ prostate cancer, in-situ cervix carcinoma, or in-situ breast cancer which have been fully removed and are considered cured.
Previous unexplained history of recurrent pre-syncope or syncope with no clear provoking features or syncope in the context of medical investigations that is likely to complicate interpretation of the safety of the drug in the opinion of the Investigator.
Veins unsuitable for intravenous (i.v.) puncture on both arms.
Participation in a clinical study involving study treatment administration within 3 months (or within 5 half-lives before screening, whichever is longer) prior to (the first) study treatment administration or in more than 3 clinical studies within 1 year prior to (the first) study treatment administration.
History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
Consumption of >14 units of alcohol per week (females) or >21 units per week (males).
Excessive caffeine consumption.
Nicotine consumption from 3 months prior to (first) study treatment administration, checked at screening and on Day -1.
Loss (including donation) of 450 mL or more of blood or blood products within 2 months prior to (the first) study treatment administration.
Positive results from serum/urine drug or alcohol screen test at screening or on Day -1.
Positive hepatitis B and/or C serology results, except for vaccinated participants or those with past but resolved hepatitis, at screening.
Positive human immunodeficiency virus (HIV) serology results at screening.
Any circumstances or conditions which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Legal incapacity or limited legal capacity at screening.
Treatment or intended treatment with any prescribed medications within 2 weeks prior to (first) study treatment administration, except for contraceptives (including hormonal contraceptive devices) in female participants (Part B and C only), and/or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 1 week prior to (first) study treatment administration. Analgesia with paracetamol is acceptable (but not NSAIDs or aspirin >75 mg per day), unless for the short-term treatment of post lumbar puncture (LP) headache. For Part C: prescribed and OTC (including vitamins and minerals) are permitted (apart from exceptions listed below) provided they have been on a stable dose in the 3 months prior to screening.
Any immunosuppressive therapies within 2 months or 5 half-lives (whichever is longer) prior to first study treatment administration.
Current or recent use (within 1 month or 5 half-lives whichever is longer) of glucagon-like peptide-1 (GLP1) receptor agonists.
Any biological compound for research or medical reasons within 12 months prior to (first) study treatment administration.
Any relevant bacterial, viral, fungal, or protozoal infection that manifested within the last 6 weeks prior to screening and/or an ongoing relevant bacterial, viral, fungal, or protozoal infection, as judged by the investigator, and/or evidence of immune dysfunction based on laboratory tests at screening. If mild infections occur during screening causing a rise in C-reactive protein (CRP), that is ≥10.0 mg/L, the participant should not be included until this has normalized.
Receipt of vaccine within 5 weeks prior to admission.
Any medical history of an active tuberculosis (TB) infection, positive test result for latent TB in the last 2 years, or any contact with TB-positive individuals in the last 4 weeks prior to screening.
Potential anticipated lack of compliance with study assessments and visit schedule.
Planned hospitalization (other than for study assessments) or surgery during the study.
Part A Food effect cohort only: Inability or unwillingness to completely consume the high-fat breakfast prior to study treatment administration.
Parts B and C only: Pregnant or lactating women.
Part B (for those undergoing LP): Contraindications for LP including, but not limited to space-occupying lesions with mass effect or raised intracranial pressure, posterior fossa mass, anticoagulant or antiplatelet medications, coagulopathy, thrombocytopenia (<150×109/L), congenital spine abnormality, skin infection at the LP site or tattoo covering puncture site.
Part B (for those undergoing LP): Lower back pain at the time of the study or history of recurrent headaches in the last 6 months (more than 4 days a month of headaches that limit normal daily activity)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

AC Immune Clinical Lead contact

+41213459121

clinicaltrials@acimmune.com

Netherlands1 site, 1 recruiting

ICON
Groningen, 9728 NZ
Recruiting

Other trials in Netherlands

About this study

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 and in Participants With Cardiovascular Risk Factors

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.

Read the detailed description

In study Part A (SAD part), up to 6 dose levels with 8 male participants in each are planned (6 participants on ACI-19764 and 2 on placebo). Each cohort has a screening period followed by admission to the site for administration of ACI-19764 or placebo. Participants remain onsite for observation for 3 days. Participants may need to return for additional visits for 2 days after discharge to check the blood levels of the drug. A safety follow up call is planned approximately 3 weeks after discharge. In one of the higher dose cohorts, the effect of food on drug levels in the blood will also be explored with an additional admission. There may be fewer than 6 cohorts.

In study Part B (MAD part), up to 3 dose levels with 10 participants (8 on active and 2 on placebo) in each are planned. Each dose level will be investigated in a separate cohort of 10 healthy male and female participants (with 4 participants of each sex on active treatment and 1 of each sex on placebo). Each cohort has a screening period followed by admission to the site for 17 days (14-day treatment and 3 days observation). Depending on the blood levels of the drug, participants may have to return to the site for additional blood tests for the 2 days following discharge. A safety phone call is planned approximately 3 weeks after discharge.

In study Part C, a single cohort of 36 participants (18 on active and 18 on placebo) with cardiovascular risk factors is planned, including males and females. After the screening period, ACI-19764 or placebo will be administered orally once daily for 4 weeks (i.e., from Day 1 up to and including Day 28). Study participants will be confined to the study site from Day -1 up to Day 2 and from Day 28 to Day 29. In between, they will return to the study site for ambulatory visits on Day 10 and Day 17. When not on site, participants will take ACI-19764 or placebo daily at home. Participants will return to the study site on Day 31 for an ambulatory visit for blood collection. Depending on the blood levels of the drug, participants may have to return to the site on Day 35 for additional blood tests. A safety phone call is planned approximately 3 weeks after discharge.

Conditions: Healthy Participants, Obesity, Type 2 Diabetes Mellitus (T2DM)
Being tested: Placebo, ACI-19764 at dose A1, ACI-19764 at dose A2, ACI-19764 at dose A3, ACI-19764 at dose A4
Keywords: Phase 1, Healthy Participants, SAD/MAD, NLRP3 inhibitor, Pharmacokinetics, Obesity, Diabetes, Cardiovascular risks
Medical subject headings: Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Placebo capsules matching ACI-19764 capsules
ACI-19764 at dose A1Drug
ACI-19764 capsules at dose A1
ACI-19764 at dose A2Drug
ACI-19764 capsules at dose A2
ACI-19764 at dose A3Drug
ACI-19764 capsules at dose A3
ACI-19764 at dose A4Drug
ACI-19764 capsules at dose A4
ACI-19764 at dose A5Drug
ACI-19764 capsules at dose A5
ACI-19764 at dose A6Drug
ACI-19764 capsules at dose A6
ACI-19764 at dose B1Drug
ACI-19764 capsules at dose B1
ACI-19764 at dose B2Drug
ACI-19764 capsules at dose B2
ACI-19764 at dose B3Drug
ACI-19764 capsules at dose B3
ACI-19764 at dose C1Drug
ACI-19764 capsules at dose C1

Study groups in NCT07463196
Study group	Role	What they receive
Placebo for study Part A (SAD)	Placebo comparator	Participants receive a single oral dose of placebo Receives: Drug: Placebo
ACI-19764 at dose A1 for study Part A (SAD)	Experimental	Participants receive a single oral dose A1 of ACI-19764 Receives: Drug: ACI-19764 at dose A1
ACI-19764 at dose A2 for study Part A (SAD) (optional)	Experimental	Participants receive a single oral dose A2 of ACI-19764 Receives: Drug: ACI-19764 at dose A2
ACI-19764 at dose A3 for study Part A (SAD) (optional)	Experimental	Participants receive a single oral dose A3 of ACI-19764 Receives: Drug: ACI-19764 at dose A3
ACI-19764 at dose A4 for study Part A (SAD) (optional)	Experimental	Participants receive a single oral dose A4 of ACI-19764 Receives: Drug: ACI-19764 at dose A4
ACI-19764 at dose A5 for study Part A (SAD) (optional)	Experimental	Participants receive a single oral dose A5 of ACI-19764 Receives: Drug: ACI-19764 at dose A5
ACI-19764 at dose A6 for study Part A (SAD) (optional)	Experimental	Participants receive a single oral dose A6 of ACI-19764 Receives: Drug: ACI-19764 at dose A6
Placebo for study Part B (MAD)	Placebo comparator	Participants receive multiple oral doses of placebo Receives: Drug: Placebo
ACI-19764 at dose B1 for study Part B (MAD)	Experimental	Participants receive multiple oral doses B1 of ACI-19764 Receives: Drug: ACI-19764 at dose B1
ACI-19764 at dose B2 for study Part B (MAD) (optional)	Experimental	Participants receive multiple oral doses B2 of ACI-19764 Receives: Drug: ACI-19764 at dose B2
ACI-19764 at dose B3 for study Part B (MAD) (optional)	Experimental	Participants receive multiple oral doses B3 of ACI-19764 Receives: Drug: ACI-19764 at dose B3
Placebo for study Part C	Placebo comparator	Participants receive multiple oral doses of placebo Receives: Drug: Placebo
ACI-19764 at dose C1 for study Part C	Experimental	Participants receive multiple oral doses C1 of ACI-19764 Receives: Drug: ACI-19764 at dose C1

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely related, possibly related or probably related)
Measured: From first study treatment administration up to the end of the safety follow-up (i.e. 21 to 24 days after Day 4 for study Part A, 21 to 24 days after Day 17 for study Part B, and 21 to 24 days after Day 29 for study Part C)
Vital signs: Change from baseline in blood pressure
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Vital signs: Change from baseline in respiratory rate
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Vital signs: Change from baseline in pulse rate
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Vital signs: Change from baseline in body temperature
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in heart rate
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in PR interval
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QRS interval
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QT interval
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QTcF interval
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QTcB interval
Measured: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Applicable to study Parts B and C only
Measured: From baseline up to the end of the treatment and observation period (i.e. Day 17 for study Part B and Day 28 for study Part C)
Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax), stratified by sex
Measured: From baseline to up to the end of the treatment and observation period (i.e. Day 4 for study Part A, Day 17 for study Part B, and Day 28 for study Part C)
Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax), stratified by sex
Measured: From baseline to up to the end of the treatment and observation period (i.e. Day 4 for study Part A, Day 17 for study Part B, and Day 28 for study Part C)
Pharmacokinetic (PK) in plasma: Area under the curve (AUC) from time zero to the last measured concentration above the limit of quantification (AUC 0-last)
Applicable to study Part A only
Measured: From baseline to up to the end of the treatment and observation period (i.e. Day 4)
Pharmacokinetic (PK) in plasma: AUC from time zero to infinity (AUC 0-infinity)
Applicable to study Part A only
Measured: From baseline to up to the end of the treatment and observation period (i.e. Day 4)
Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½)
Applicable to study Part A only
Measured: From baseline to up to the end of the treatment and observation period (i.e. Day 4)
Pharmacokinetic (PK) in plasma: Dose proportionality for Cmax and AUC 0-infinity
Applicable to study Part A only
Measured: From baseline to up to the end of the treatment and observation period (i.e. Day 4)
Pharmacokinetic (PK) in plasma: AUCtau (AUC of one dosing interval) after first and last study treatment administration, stratified by sex
Applicable to study Parts B and C only
Measured: From baseline to up to the end of the treatment period (i.e. Day 15 for study Part B and Day 29 for study Part C)
Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½) after last study treatment administration, stratified by sex
Applicable to study Parts B and C only
Measured: From baseline to up to the last timepoint measured (i.e. Day 19 for study Part B and 21 to 24 days after Day 29 for study Part C)
Pharmacokinetic (PK) in plasma: Average plasma concentration at steady state (Cavg,ss) during the last dosing interval, stratified by sex
Applicable to study Parts B and C only
Measured: From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)
Pharmacokinetic (PK) in plasma: Minimum plasma concentration at steady state (Cmin,ss) during the last dosing interval, stratified by sex
Applicable to study Parts B and C only
Measured: From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)
Pharmacokinetic (PK) in plasma: Trough (pre-dose) plasma concentrations (Ctrough), stratified by sex
Applicable to study Parts B and C only
Measured: From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)
Pharmacokinetic (PK) in plasma: Accumulation index (AI) for Cmax and AUCtau, stratified by sex
Applicable to study Parts B and C only
Measured: From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)
Pharmacokinetic (PK) in CSF: Drug concentration at steady state (trough level capturing Cmin), stratified by sex
Applicable to study Part B2 and B3 only
Measured: From baseline to Day 13

Secondary outcomes (11)

Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax) in fed state
Applicable to study Part A Food Effect group only
Measured: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax) in fed state
Applicable to study Part A Food Effect group only
Measured: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Area under the curve (AUC) from time zero to the last measured concentration above the limit of quantification (AUC 0-last), in fed state
Applicable to study Part A Food Effect group only
Measured: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: AUC from time zero to infinity (AUC 0-infinity) in fed state
Applicable to study Part A Food Effect group only
Measured: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½) in fed state
Applicable to study Part A Food Effect group only
Measured: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Dose proportionality for Cmax and AUC 0-infinity in fed state
Applicable to study Part A Food Effect group only
Measured: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacodynamic (PD) effect of ACI-19764 (target engagement [TE]) after SAD and MAD administration of ACI-19764 in healthy participants and of one multiple-dose level in participants with cardiovascular risk factors, stratified by sex
Change from baseline in PD parameters. Given as % of target engagement in whole blood assay (i.e. Inhibition of IL-1β release after ex vivo LPS and ATP stimulation)
Measured: From baseline up to the last timepoint measured (i.e. Day 4 for study Part A, Day 19 for study Part B, and 21 to 24 days after Day 29 for study Part C)
Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors
Proportion of participants with serum C-reactive protein (CRP) <2 mg/L after 4 weeks of treatment. Applicable to study Part C only
Measured: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)
Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors
Proportion of participants with serum C-reactive protein (CRP) <1 mg/L after 4 weeks of treatment. Applicable to study Part C only
Measured: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)
Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors
Percentage change from baseline in serum C-reactive protein (CRP) after 4 weeks of treatment. Applicable to study Part C only
Measured: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)
Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors
Absolute change from baseline in serum C-reactive protein (CRP) after 4 weeks of treatment. Applicable to study Part C only
Measured: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 2026Dec 2026

First posted11 Mar 2026
Study start28 Jan 2026
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 114 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07463196
Sponsor's protocol ID: ACI-19764-2501
Other IDs: 2025-523885-25-00, 2025
Status last verified: Aug 2026
First submitted: 18 Feb 2026
Last updated: 2 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

AC Immune Clinical Lead

+41213459121

clinicaltrials@acimmune.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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 and in Participants With Cardiovascular Risk Factors
ClinicalTrials.gov ID: NCT07463196
Acronym / sponsor ID: ACI-19764-2501
Conditions: Healthy Participants, Obesity, Type 2 Diabetes Mellitus (T2DM)
Keywords: Phase 1, Healthy Participants, SAD/MAD, NLRP3 inhibitor, Pharmacokinetics, Obesity, Diabetes, Cardiovascular risks
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 114 participants (estimated)
Lead sponsor: AC Immune SAIndustry (pharma, biotech, devices)
Collaborators: ICON Clinical Research
Study start: 28 Jan 2026 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 11 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 13

Arm	Type	Receives
Placebo for study Part A (SAD)	Placebo comparator	Drug: PlaceboParticipants receive a single oral dose of placebo
ACI-19764 at dose A1 for study Part A (SAD)	Experimental	Drug: ACI-19764 at dose A1Participants receive a single oral dose A1 of ACI-19764
ACI-19764 at dose A2 for study Part A (SAD) (optional)	Experimental	Drug: ACI-19764 at dose A2Participants receive a single oral dose A2 of ACI-19764
ACI-19764 at dose A3 for study Part A (SAD) (optional)	Experimental	Drug: ACI-19764 at dose A3Participants receive a single oral dose A3 of ACI-19764
ACI-19764 at dose A4 for study Part A (SAD) (optional)	Experimental	Drug: ACI-19764 at dose A4Participants receive a single oral dose A4 of ACI-19764
ACI-19764 at dose A5 for study Part A (SAD) (optional)	Experimental	Drug: ACI-19764 at dose A5Participants receive a single oral dose A5 of ACI-19764
ACI-19764 at dose A6 for study Part A (SAD) (optional)	Experimental	Drug: ACI-19764 at dose A6Participants receive a single oral dose A6 of ACI-19764
Placebo for study Part B (MAD)	Placebo comparator	Drug: PlaceboParticipants receive multiple oral doses of placebo
ACI-19764 at dose B1 for study Part B (MAD)	Experimental	Drug: ACI-19764 at dose B1Participants receive multiple oral doses B1 of ACI-19764
ACI-19764 at dose B2 for study Part B (MAD) (optional)	Experimental	Drug: ACI-19764 at dose B2Participants receive multiple oral doses B2 of ACI-19764
ACI-19764 at dose B3 for study Part B (MAD) (optional)	Experimental	Drug: ACI-19764 at dose B3Participants receive multiple oral doses B3 of ACI-19764
Placebo for study Part C	Placebo comparator	Drug: PlaceboParticipants receive multiple oral doses of placebo
ACI-19764 at dose C1 for study Part C	Experimental	Drug: ACI-19764 at dose C1Participants receive multiple oral doses C1 of ACI-19764

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
Healthy male (Parts A and B) or female (Part B) aged between 18 and 65 years (inclusive) at screening or, male or female with cardiovascular risk factors between 18 and 75 years (inclusive) (Part C).
For Parts A and B: Body mass index of 18.0 to 29.9 kg/m2 (inclusive) at screening.
For Part C: Presence of either obesity (defined as a BMI of 30.0-42.0 kg/m2 inclusive) and/or existing diagnosis of well controlled type II diabetes (with HbA1c >6.5% or 48 mmol/mol and ≤8.5% or 69 mmol/mol) (for participants with diabetes the BMI can range between 18.0-42.0 kg/m2 inclusive).
For Part C: serum CRP >3.0 mg/L and <10.0 mg/L at screening and reconfirmed prior first dosing.

Key exclusion criteria (37 listed)

Known hypersensitivity to any excipient of the ACI-19764 formulations.
Known clinically relevant hypersensitivity or allergy to any therapeutic treatment (including non-steroidal anti-inflammatory drugs [NSAIDs], or nucleotide-binding oligomerization domain-like receptor family pyrin domain-containing 3 [NLRP3] inhibitors), vaccines, cosmetics, natural rubber or latex and/or food.
Clinically relevant findings on the physical examination at screening or on Day -1.
Clinically relevant findings in clinical laboratory tests
Clinically relevant history or presence of rhythm disorders, congestive heart failure, or structural heart disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo capsules matching ACI-19764 capsules	Drug	Placebo for study Part A (SAD), Placebo for study Part B (MAD), Placebo for study Part C
ACI-19764 at dose A1ACI-19764 capsules at dose A1	Drug	ACI-19764 at dose A1 for study Part A (SAD)
ACI-19764 at dose A2ACI-19764 capsules at dose A2	Drug	ACI-19764 at dose A2 for study Part A (SAD) (optional)
ACI-19764 at dose A3ACI-19764 capsules at dose A3	Drug	ACI-19764 at dose A3 for study Part A (SAD) (optional)
ACI-19764 at dose A4ACI-19764 capsules at dose A4	Drug	ACI-19764 at dose A4 for study Part A (SAD) (optional)
ACI-19764 at dose A5ACI-19764 capsules at dose A5	Drug	ACI-19764 at dose A5 for study Part A (SAD) (optional)
ACI-19764 at dose A6ACI-19764 capsules at dose A6	Drug	ACI-19764 at dose A6 for study Part A (SAD) (optional)
ACI-19764 at dose B1ACI-19764 capsules at dose B1	Drug	ACI-19764 at dose B1 for study Part B (MAD)
ACI-19764 at dose B2ACI-19764 capsules at dose B2	Drug	ACI-19764 at dose B2 for study Part B (MAD) (optional)
ACI-19764 at dose B3ACI-19764 capsules at dose B3	Drug	ACI-19764 at dose B3 for study Part B (MAD) (optional)
ACI-19764 at dose C1ACI-19764 capsules at dose C1	Drug	ACI-19764 at dose C1 for study Part C

Primary outcome

Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely related, possibly related or probably related)
Time frame: From first study treatment administration up to the end of the safety follow-up (i.e. 21 to 24 days after Day 4 for study Part A, 21 to 24 days after Day 17 for study Part B, and 21 to 24 days after Day 29 for study Part C)
Vital signs: Change from baseline in blood pressure
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Vital signs: Change from baseline in respiratory rate
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Vital signs: Change from baseline in pulse rate
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Vital signs: Change from baseline in body temperature
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in heart rate
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in PR interval
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QRS interval
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QT interval
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QTcF interval
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
ECG: Change from baseline in QTcB interval
Time frame: From baseline up to the end of the treatment and observation period for Parts A and B (i.e. Day 4 for study Part A and Day 17 for study Part B), and up to the end of the safety follow-up for Part C (i.e. 21 to 24 days after Day 29)
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From baseline up to the end of the treatment and observation period (i.e. Day 17 for study Part B and Day 28 for study Part C)
Applicable to study Parts B and C only
Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax), stratified by sex
Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4 for study Part A, Day 17 for study Part B, and Day 28 for study Part C)
Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax), stratified by sex
Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4 for study Part A, Day 17 for study Part B, and Day 28 for study Part C)
Pharmacokinetic (PK) in plasma: Area under the curve (AUC) from time zero to the last measured concentration above the limit of quantification (AUC 0-last)
Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4)
Applicable to study Part A only
Pharmacokinetic (PK) in plasma: AUC from time zero to infinity (AUC 0-infinity)
Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4)
Applicable to study Part A only
Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½)
Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4)
Applicable to study Part A only
Pharmacokinetic (PK) in plasma: Dose proportionality for Cmax and AUC 0-infinity
Time frame: From baseline to up to the end of the treatment and observation period (i.e. Day 4)
Applicable to study Part A only
Pharmacokinetic (PK) in plasma: AUCtau (AUC of one dosing interval) after first and last study treatment administration, stratified by sex
Time frame: From baseline to up to the end of the treatment period (i.e. Day 15 for study Part B and Day 29 for study Part C)
Applicable to study Parts B and C only
Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½) after last study treatment administration, stratified by sex
Time frame: From baseline to up to the last timepoint measured (i.e. Day 19 for study Part B and 21 to 24 days after Day 29 for study Part C)
Applicable to study Parts B and C only
Pharmacokinetic (PK) in plasma: Average plasma concentration at steady state (Cavg,ss) during the last dosing interval, stratified by sex
Time frame: From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)
Applicable to study Parts B and C only
Pharmacokinetic (PK) in plasma: Minimum plasma concentration at steady state (Cmin,ss) during the last dosing interval, stratified by sex
Time frame: From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)
Applicable to study Parts B and C only
Pharmacokinetic (PK) in plasma: Trough (pre-dose) plasma concentrations (Ctrough), stratified by sex
Time frame: From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)
Applicable to study Parts B and C only
Pharmacokinetic (PK) in plasma: Accumulation index (AI) for Cmax and AUCtau, stratified by sex
Time frame: From baseline to up to the end of the treatment period (i.e. Day 14 for study Part B and D28 for study Part C)
Applicable to study Parts B and C only
Pharmacokinetic (PK) in CSF: Drug concentration at steady state (trough level capturing Cmin), stratified by sex
Time frame: From baseline to Day 13
Applicable to study Part B2 and B3 only

11 secondary outcomes

Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax) in fed state
Time frame: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax) in fed state
Time frame: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Area under the curve (AUC) from time zero to the last measured concentration above the limit of quantification (AUC 0-last), in fed state
Time frame: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: AUC from time zero to infinity (AUC 0-infinity) in fed state
Time frame: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½) in fed state
Time frame: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacokinetic (PK) in plasma: Dose proportionality for Cmax and AUC 0-infinity in fed state
Time frame: From baseline up to the end of the treatment and observation period (i.e. Day 4) of the 2nd study period for the Food Effect group
Pharmacodynamic (PD) effect of ACI-19764 (target engagement [TE]) after SAD and MAD administration of ACI-19764 in healthy participants and of one multiple-dose level in participants with cardiovascular risk factors, stratified by sex
Time frame: From baseline up to the last timepoint measured (i.e. Day 4 for study Part A, Day 19 for study Part B, and 21 to 24 days after Day 29 for study Part C)
Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors
Time frame: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)
Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors
Time frame: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)
Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors
Time frame: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)
Peripheral Pharmacodynamic (PD) effect of ACI-19764 in participants with cardiovascular risk factors
Time frame: From baseline up to the end of the 4-weeks treatment period (i.e. Day 28)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AC Immune Clinical Lead contact

+41213459121

clinicaltrials@acimmune.com

Principal Investigator principal investigator

ICON plc

Clinical Lead study director

AC Immune SA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACI-19764 at dose A1, ACI-19764 at dose A2 and ACI-19764 at dose A3 in people with Healthy Participants and Obesity, run by AC Immune SA at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AC Immune Clinical Lead (+41213459121, clinicaltrials@acimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely related, possibly related or probably related) (time frame: From first study treatment administration up to the end of the safety follow-up (i.e. 21 to 24 days after Day 4 for study Part A, 21 to 24 days after Day 17 for study Part B, and 21 to 24 days after Day 29 for study Part C)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07463196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.