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.
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.
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
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Treatment groupsSee each treatment group below.
AC Immune SA
Lead sponsor
ICON Clinical Research
Collaborator