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Monoclonal Antibodies

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1)

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 57 to day 225

Summary

This trial tests ABBV-382, a new drug for treating HIV-1. It involves adults with HIV-1 who are either untreated or on stable treatment. The study aims to see how the drug is absorbed, distributed, and eliminated by the body.

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 57 to day 225
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 57 to day 225 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC During the 4-Week Dosing Interval (AUCtau) of ABBV-382 (Part B)
Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382 (Part A)
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382 (Part A)
+7 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: Subcutaneous Cohort: ABBV-382Experimental Treatment1 Intervention
Participants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57.
Group II: Part B: Intravenous Cohort: ABBV-382 Dose BExperimental Treatment1 Intervention
Participants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57.
Group III: Part B: Intravenous Cohort: ABBV-382 Dose AExperimental Treatment1 Intervention
Participants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57.
Group IV: Part A: ABBV-382 Dose BExperimental Treatment1 Intervention
Participants will receive intravenous (IV) ABBV-382 dose B on Day 1.
Group V: Part A: ABBV-382 Dose AExperimental Treatment1 Intervention
Participants will receive intravenous (IV) ABBV-382 dose A on Day 1.
Group VI: Part B: Intravenous Cohort: Placebo for ABBV-382 Dose APlacebo Group1 Intervention
Participants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57.
Group VII: Part B: Intravenous Cohort: Placebo for ABBV-382 Dose BPlacebo Group1 Intervention
Participants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-382
2021
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,035 Previous Clinical Trials
522,990 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,639 Total Patients Enrolled
~12 spots leftby Dec 2025
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