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RECRUITING
NCT07306754
PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-12-17

Completion Date

2027-05

Last Updated

2026-01-12

Healthy Volunteers

Yes

Interventions

DRUG

ABBV-243

Intravenous (IV) Infusion

DRUG

Placebo

Intravenous (IV) Infusion

DRUG

ABBV-243

Subcutaneous (SC) Injection

DRUG

Placebo

Subcutaneous (SC) Injection

Locations (1)

Acpru /Id# 279789

Grayslake, Illinois, United States