Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Trosunilimab
ABBV-382 · 1 trial · 1 indication
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either "Reasonable Possibility" or "No Reasonable Possibility" and will assess the severity of each adverse event from Grade 1 (mild) to Grade 4 (potentially life-threatening).
Maximum observed serum concentration (Cmax) of ABBV-382.
Time to Cmax (Tmax) of ABBV-382.
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382.
AUC from time 0 to infinite time (AUCinf) of ABBV-382.
Terminal phase elimination rate constant of ABBV-382.
Terminal phase elimination half-life of ABBV-382.
Observed concentration at the end of the 4-week dosing interval (Ctrough) of ABBV-382.
AUC during the 4-week dosing interval (AUCtau) of ABBV-382.
Terminal phase elimination half-life (t1/2) of ABBV-382 will be estimated after the third dose only.
| Arm | Type | Description |
|---|---|---|
| Part A: ABBV-382 Dose A | EXPERIMENTAL | Participants will receive intravenous (IV) ABBV-382 dose A on Day 1. |
| Part A: ABBV-382 Dose B | EXPERIMENTAL | Participants will receive intravenous (IV) ABBV-382 dose B on Day 1. |
| Part B: Intravenous Cohort: ABBV-382 Dose A | EXPERIMENTAL | Participants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57. |
| Part B: Intravenous Cohort: Placebo for ABBV-382 Dose A | PLACEBO_COMPARATOR | Participants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57. |
| Part B: Intravenous Cohort: ABBV-382 Dose B | EXPERIMENTAL | Participants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57. |
| Part B: Intravenous Cohort: Placebo for ABBV-382 Dose B | PLACEBO_COMPARATOR | Participants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57. |
| Part B: Subcutaneous Cohort: ABBV-382 | EXPERIMENTAL | Participants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57. |
| Name | Type | Description |
|---|---|---|
| ABBV-382 | DRUG | Intravenous (IV) infusion |
| Placebo for ABBV-382 | DRUG | Intravenous (IV) infusion |
Inclusion Criteria: * Body Mass Index (BMI) is \>= 18.0 to \<= 35.0 kg/m\^2 after rounding to the tenths decimal. * Must agree to use effective barrier protection during sexual activity for protection against Human Immunodeficiency Virus (HIV)-1 transmission through the last study visit. * Female p...
ABBV-382 is an investigational small molecule being developed by AbbVie Inc. for human immunodeficiency virus, or HIV. It has been studied in a Phase 1 clinical trial in adults with HIV-1 infection. It is not described as an approved product and remains in clinical development.
ABBV-382 is being studied for the treatment of human immunodeficiency virus type 1, HIV-1, in adults. The Phase 1 trial enrolled adult participants with HIV-1 infection rather than healthy volunteers. Its use in this setting is investigational and has not been established as an approved therapy.
ABBV-382 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the Phase 1 study of the compound in adults with HIV-1 infection. The drug remains an investigational asset in the company's pipeline.
ABBV-382 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are listed. The study was a randomized, double-blind, placebo-controlled trial that enrolled 54 adult participants with HIV-1 infection in the United States and Puerto Rico.
ABBV-382 has been evaluated in one Phase 1 trial, NCT04554966, titled a study to assess adverse events and how intravenous or subcutaneous ABBV-382 moves through the body of adult participants with HIV-1. That trial is completed, enrolled 54 participants, and was randomized, double-blind, and placebo-controlled.
ABBV-382 was studied as both an intravenous and a subcutaneous formulation in its Phase 1 trial. The study assessed adverse events and how the drug moves through the body of adult participants with HIV-1 after intravenous or subcutaneous administration. It is a small molecule and remains investigational.