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Healthy volunteersDrugPhase 1

What this study is

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.

What's being tested

  • ABBV-243

    Intervention · DRUG

  • Placebo

    Intervention · DRUG

  • ABBV-243

    Intervention · DRUG

  • Placebo

    Intervention · DRUG

Both ABBV-243 and Placebo

Intravenous (IV) Infusion

Both ABBV-243 and Placebo

Subcutaneous (SC) Injection

Study details

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
Sponsor
AbbVie
Conditions
Healthy Volunteers
Enrolling
66 people
Starts
2025-12-17
Est. completion
2027-05
Design
Double-blind, randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗