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ACI-19764 at dose A1

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

Ensayo de AC Immune SA en Healthy Participants · Obesity · Type 2 Diabetes Mellitus (T2DM) (del registro, en inglés).

Más ensayos de: Obesidad.

Fase

Fase 1

Estado

Reclutando pacientes

Participantes

114

previstos

Centros

1

Fin del objetivo primario

dic 2026

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ene 2026.

Lo que ha cambiado

Movimientos registrados desde que PivotalWire vigila este ensayo. Un retraso no se anuncia: se ve comparando, y esto es la comparación ya hecha.

Qué mide

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, 21 to 24 days after Day 17 for study Part B, and 21 to 24 days after Day 29 for study Part C)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de ACIU

Todos los de ACIU, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07463196), actualizada en ago 2026.