NCT07306754

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

A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses (SAD) of ABBV-243 in Healthy Adult Subjects and a Single Dose in Healthy Asian Adult Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the safety, tolerability, pharmacokinetics and immunogenicity of either single ascending intravenous (IV) doses of ABBV-243 or single ascending subcutaneous (SC) doses of ABBV-243 in healthy adult participants (Part 1), and a single intravenous (IV) dose in healthy Asian adult volunteers (Part 2 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 Volunteers

Interventions

Type	Name	Description
DRUG	ABBV-243	Intravenous (IV) Infusion
DRUG	Placebo	Intravenous (IV) Infusion
DRUG	ABBV-243	Subcutaneous (SC) Injection
DRUG	Placebo	Subcutaneous (SC) Injection

Timeline

• Start date: 2025-12-17
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-12-29
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study