Phase 1 Study to Evaluate Safety and How ABBV-243 Moves Through the Body After Single Doses in Healthy Adults Including Asian Volunteers

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and immune response of ABBV-243, a drug given by intravenous IV or subcutaneous SC injection, in healthy adult volunteers. This Phase 1 trial includes two parts Part 1 tests single ascending doses of ABBV-243 or placebo in healthy adults, and Part 2 evaluates a single IV dose in healthy Asian adults. The study aims to understand how ABBV-243 behaves in the body and its safety profile. Participants will receive either a single IV or SC dose of ABBV-243 or a matching placebo on Day 1. Different groups will get varying doses to assess the effects and how the drug is processed. Specific groups include Han Chinese and Japanese adults who will receive a single IV dose or placebo. The study uses a randomized, double-blind design to compare ABBV-243 against placebo. During the study, participants will attend multiple visits at a hospital or clinic for medical assessments, blood tests, and questionnaires to monitor side effects and drug levels. The main outcomes measured include the number of adverse events, maximum drug concentration in blood, time to reach this concentration, overall drug exposure over time, drug elimination rate, half-life, and the presence of antibodies against ABBV-243. Participants will be followed for safety and drug effects up to Day 204 after dosing.

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.