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

ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAC Immune SA

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Body mass index of 18.0 to 29.9 kg/m2 (inclusive) at screening.

Ability to communicate well with the investigator, and to understand and comply with the study requirements.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    Placebo capsules matching ACI-19764 capsules

  • ACI-19764 at dose A1

    Drug

    ACI-19764 capsules at dose A1

  • ACI-19764 at dose A2

    Drug

    ACI-19764 capsules at dose A2

  • ACI-19764 at dose A3

    Drug

    ACI-19764 capsules at dose A3

  • ACI-19764 at dose A4

    Drug

    ACI-19764 capsules at dose A4

  • ACI-19764 at dose A5

    Drug

    ACI-19764 capsules at dose A5

  • ACI-19764 at dose A6

    Drug

    ACI-19764 capsules at dose A6

  • ACI-19764 at dose B1

    Drug

    ACI-19764 capsules at dose B1

  • ACI-19764 at dose B2

    Drug

    ACI-19764 capsules at dose B2

  • ACI-19764 at dose B3

    Drug

    ACI-19764 capsules at dose B3

Treatment groups

78 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Placebo for study Part A (SAD)Placebo comparator 1 intervention
Group B: ACI-19764 at dose A1 for study Part A (SAD)Experimental treatment 1 intervention
Group C: ACI-19764 at dose A2 for study Part A (SAD) (optional)Experimental treatment 1 intervention
Group D: ACI-19764 at dose A3 for study Part A (SAD) (optional)Experimental treatment 1 intervention
Group E: ACI-19764 at dose A4 for study Part A (SAD) (optional)Experimental treatment 1 intervention
Group F: ACI-19764 at dose A5 for study Part A (SAD) (optional)Experimental treatment 1 intervention
Group G: ACI-19764 at dose A6 for study Part A (SAD) (optional)Experimental treatment 1 intervention
Group H: Placebo for study Part B (MAD)Placebo comparator 1 intervention
Group I: ACI-19764 at dose B1 for study Part B (MAD)Experimental treatment 1 intervention
Group J: ACI-19764 at dose B2 for study Part B (MAD) (optional)Experimental treatment 1 intervention
Group K: ACI-19764 at dose B3 for study Part B (MAD) (optional)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 and 21 to 24 days after Day 17 for study Part B)
2

Vital signs: Change from baseline in blood pressure

Time frame
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)
3

Vital signs: Change from baseline in respiratory rate

Time frame
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)
4

Vital signs: Change from baseline in pulse rate

Time frame
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)

Secondary outcomes

1

Pharmacokinetic (PK) in plasma: Maximum observed concentration (Cmax) in fed state

Applicable to study Part A Food Effect group only

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
2

Pharmacokinetic (PK) in plasma: Time to reach Cmax (tmax) in fed state

Applicable to study Part A Food Effect group only

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
3

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

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
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AC Immune SA

Lead sponsor

ICON Clinical Research

Collaborator

Source ClinicalTrials.gov
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