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

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT07306754
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • ABBV-243 — DRUG
    Intravenous (IV) Infusion
  • Placebo — DRUG
    Intravenous (IV) Infusion
  • ABBV-243 — DRUG
    Subcutaneous (SC) Injection
  • Placebo — DRUG
    Subcutaneous (SC) Injection

Study Details

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.

Key Dates

Start date
Dec 17, 2025
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: ABBV-243 or Placebo
    Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
  • Experimental: Group 2: ABBV-243 or Placebo
    Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
  • Experimental: Group 3: ABBV-243 or Placebo
    Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
  • Experimental: Group 4: ABBV-243 or Placebo
    Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
  • Experimental: Group 5: ABBV-243 or Placebo
    Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1
  • Experimental: Group 6: ABBV-243 or Placebo
    Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1
  • Experimental: Group 7: ABBV-243 or Placebo
    Han Chinese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
  • Experimental: Group 8: ABBV-243 or Placebo
    Japanese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Day 204 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Acpru /Id# 279789GrayslakeIllinois60030-

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Acpru· Grayslake, IL

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