Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04554966 | 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) | PHASE1 | COMPLETED | 54 | — | — | Apr 16, 2021 | Aug 14, 2023 | Mar 4, 2024 | 21 | United States, Puerto Rico |
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...