A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT06673238
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • ABBV-722 — DRUG
    Oral Capsule
  • Placebo — DRUG
    Oral Capsule

Study Details

This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.

Key Dates

Start date
Oct 29, 2024
Status verified
Jul 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Group 1
    Participants will receive a single dose of either ABBV-722 Dose A or placebo.
  • Experimental: Part 1: Group 2
    Participants will receive a single dose of either ABBV-722 Dose B or placebo.
  • Experimental: Part 1: Group 3
    Participants will receive a single dose of either ABBV-722 Dose C or placebo.
  • Experimental: Part 1: Group 4
    Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.
  • Experimental: Part 1: Group 5
    Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.
  • Experimental: Part 2: Group 6
    Participants who are Han Chinese will receive a single dose of ABBV-722 Dose D.
  • Experimental: Part 2: Group 7
    Participants who are Japanese will receive a single dose of ABBV-722 Dose D.
  • Experimental: Part 3: Group 8
    Participants will receive either ABBV-722 Dose E or placebo for 14 days.
  • Experimental: Part 3: Group 9
    Participants will receive either ABBV-722 Dose F or placebo for 14 days.
  • Experimental: Part 3: Group 10
    Participants will receive either ABBV-722 Dose A or placebo for 14 days.
  • Experimental: Part 3: Group 11
    Participants will receive either ABBV-722 Dose G or placebo for 14 days.
  • Experimental: Part 3: Group 12
    Participants will receive either ABBV-722 Dose TBD or placebo for 14 days.

Primary Outcome Measure

Number of Participants with Adverse Events Reported During Safety Evaluations [ Time Frame: Up to Day 44 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Acpru /Id# 270279GrayslakeIllinois60030-

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Acpru· Grayslake, IL

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