NCT07232004

A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections

A First-in-Human, Phase 1a/b, Single-Dose Study of ABBV-547 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Adult Participants and Efficacy in Adult Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess how safe, effective, and tolerable ABBV-547 is in adult participants in the United States and Japan. There will be 2 parts to this study. In Part 1, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 4 chance participants will receive placebo. In Part 2, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 7 chance participants will receive placebo. Approximately 87 adult participants will be enrolled at approximately 21 sites in the United States and Japan. Participants will be administered one dose of ABBV-547 or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	ABBV-547	Injection
DRUG	ABBV-547 Placebo	Injection

Timeline

• Start date: 2025-11-24
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-11-17
• Last updated: 2026-03-05

Locations

2 sites across 1 country: United States