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ACI-19764 at dose A1

Phase 1

Healthy Participants | Small molecule | Other |AC Immune SA|Last Updated: Mar 11, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07463196A Study Investigating the Safety, Absorption, Elimination, and the Effect on the Immune System of ACI-19764 in Healthy ParticipantsPHASE1 RECRUITING 78 — — Jan 28, 2026Aug 1, 2026Mar 11, 20261 Netherlands
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Study Endpoints
Primary Endpoints
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)
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 and 21 to 24 days after Day 17 for study Part B)
Vital signs: Change from baseline in blood pressure
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
Vital signs: Change from baseline in respiratory rate
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
Vital signs: Change from baseline in pulse rate
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
Vital signs: Change from baseline in body temperature
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
ECG: Change from baseline in heart rate
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
ECG: Change from baseline in PR interval
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
ECG: Change from baseline in QRS interval
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
ECG: Change from baseline in QT interval
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
ECG: Change from baseline in QTcF interval
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
ECG: Change from baseline in QTcB interval
From baseline up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
From baseline up to the end of the treatment and observation period (i.e. Day 17)

Applicable to study Part B only

Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax), stratified by sex
From baseline to up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax), stratified by sex
From baseline to up to the end of the treatment and observation period (i.e. Day 4 for study Part A and Day 17 for study Part B)
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)
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)
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)
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
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
From baseline to up to the end of the treatment and observation period (i.e. Day 17)

Applicable to study Part B only

Pharmacokinetic (PK) in plasma: Terminal elimination half-life (t½) after last study treatment administration, stratified by sex
From baseline to up to the end of the treatment and observation period (i.e. Day 17)

Applicable to study Part B only

Pharmacokinetic (PK) in plasma: Average plasma concentration at steady state (Cavg,ss) during the last dosing interval, stratified by sex
From baseline to up to the end of the treatment and observation period (i.e. Day 17)

Applicable to study Part B only

Pharmacokinetic (PK) in plasma: Minimum plasma concentration at steady state (Cmin,ss) during the last dosing interval, stratified by sex
From baseline to up to the end of the treatment and observation period (i.e. Day 17)

Applicable to study Part B only

Pharmacokinetic (PK) in plasma: Trough (pre-dose) plasma concentrations (Ctrough), stratified by sex
From baseline to up to the end of the treatment and observation period (i.e. Day 17)

Applicable to study Part B only

Pharmacokinetic (PK) in plasma: Accumulation index (AI) for Cmax and AUCtau, stratified by sex
From baseline to up to the end of the treatment and observation period (i.e. Day 17)

Applicable to study Part B only

Pharmacokinetic (PK) in CSF: Drug concentration at steady state (trough level capturing Cmin), stratified by sex
From baseline to Day 13

Applicable to study Part B2 and B3 only

Secondary Endpoints
Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax) in fed state
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
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
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo for study Part A (SAD)PLACEBO_COMPARATORParticipants receive a single oral dose of placebo
ACI-19764 at dose A1 for study Part A (SAD)EXPERIMENTALParticipants receive a single oral dose A1 of ACI-19764
ACI-19764 at dose A2 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A2 of ACI-19764
ACI-19764 at dose A3 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A3 of ACI-19764
ACI-19764 at dose A4 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A4 of ACI-19764
ACI-19764 at dose A5 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A5 of ACI-19764
ACI-19764 at dose A6 for study Part A (SAD) (optional)EXPERIMENTALParticipants receive a single oral dose A6 of ACI-19764
Placebo for study Part B (MAD)PLACEBO_COMPARATORParticipants receive multiple oral doses of placebo
ACI-19764 at dose B1 for study Part B (MAD)EXPERIMENTALParticipants receive multiple oral doses B1 of ACI-19764
ACI-19764 at dose B2 for study Part B (MAD) (optional)EXPERIMENTALParticipants receive multiple oral doses B2 of ACI-19764
ACI-19764 at dose B3 for study Part B (MAD) (optional)EXPERIMENTALParticipants receive multiple oral doses B3 of ACI-19764
Interventions
NameTypeDescription
PlaceboDRUGPlacebo capsules matching ACI-19764 capsules
ACI-19764 at dose A1DRUGACI-19764 capsules at dose A1
ACI-19764 at dose A2DRUGACI-19764 capsules at dose A2
ACI-19764 at dose A3DRUGACI-19764 capsules at dose A3
ACI-19764 at dose A4DRUGACI-19764 capsules at dose A4
ACI-19764 at dose A5DRUGACI-19764 capsules at dose A5
ACI-19764 at dose A6DRUGACI-19764 capsules at dose A6
ACI-19764 at dose B1DRUGACI-19764 capsules at dose B1
ACI-19764 at dose B2DRUGACI-19764 capsules at dose B2
ACI-19764 at dose B3DRUGACI-19764 capsules at dose B3
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Signed informed consent in a language understandable to the participant prior to any study-mandated procedure. 2. Healthy male (Parts A and B) or female (Part B) aged between 18 and 65 years (inclusive) at screening. 3. Body mass index of 18.0 to 29.9 kg/m2 (inclusive) at scr...

Countries:Netherlands
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07463196primaryCompletionDate: changed
LOWMay 24, 2026NCT07463196studyFirstPostDate: changed