Phase 1 Study to Evaluate Safety, Tolerability, and How Oral ABBV-1042 Is Processed in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how oral doses of ABBV-1042 move through the body in healthy adult participants. This Phase 1 study aims to understand potential adverse events and how the drug is processed in the body after administration. It is a first-in-human trial sponsored by AbbVie to gather initial safety and pharmacokinetic data in adults aged 18 to 55 years in good health. Participants are randomly assigned to receive a single oral dose of either ABBV-1042 or a placebo on Day 1. The study uses a double-blind design where neither the participants nor the researchers know who receives the drug or placebo. There are multiple groups receiving ascending doses to evaluate different safety and pharmacokinetic profiles. The intervention is an oral solution taken once during the study. During the study, participants will be monitored closely for up to about 32 days to track any adverse events and changes in vital signs, physical exams, electrocardiograms ECG, laboratory tests, and mental health status using the Columbia-Suicide Severity Rating Scale C-SSRS. Blood samples will be collected to measure drug concentrations and how the body metabolizes ABBV-1042. The monitoring period for most assessments is about 3 days post-dose, with extended safety follow-up. Total participation time is approximately one month.

A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants