Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-382 · 2 trials · 2 indications
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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.
Confirmed Positive ADA Results.
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 |
|---|---|---|
| ABBV-382 Dose A | EXPERIMENTAL | Participant will receive a single dose of ABBV-382 Dose A on Day 1 and will be confined to the study site and supervised for approximately 9 days. Participants will be followed-up for approximately 20 weeks. |
| ABBV-382 Dose A Placebo | PLACEBO_COMPARATOR | Participant will receive a single dose of ABBV-382 Dose A placebo on Day 1 and will be confined to the study site and supervised for approximately 9 days. Participants will be followed-up for approximately 20 weeks. |
| ABBV-382 Dose B | EXPERIMENTAL | Participant will receive a single dose of ABBV-382 Dose B on Day 1 and will be confined to the study site and supervised for approximately 5 days. Participants will be followed-up for approximately 20 weeks. |
| ABBV-382 Dose B Placebo | PLACEBO_COMPARATOR | Participant will receive a single dose of ABBV-382 Dose B placebo on Day 1 and will be confined to the study site and supervised for approximately 5 days. Participants will be followed-up for approximately 20 weeks. |
| 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 | Subcutaneous (SC) Injection |
| Placebo for ABBV-382 | DRUG | IV Infusion |
Inclusion Criteria: * Body Mass Index (BMI) is \>= 18.0 to \<= 27.9 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters. * Females, Non-Childbearing Potential: * Premenopausal female with permanent sterility or infert...
ABBV-382 is an investigational small molecule being studied for use in Human Immunodeficiency Virus (HIV) and in healthy volunteers. It is being developed by AbbVie Inc. and is currently in Phase 1 clinical development.
ABBV-382 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 1 clinical trials.
ABBV-382 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are being conducted to evaluate its safety and how it moves through the body.
ABBV-382 has been studied in two completed Phase 1 trials. NCT04554966 evaluated intravenous and subcutaneous doses in adults with HIV-1 in the United States and Puerto Rico. NCT06632938 evaluated subcutaneous and intravenous doses in healthy adult volunteers in China.
ABBV-382 is the primary name for this investigational drug. No alternative names have been reported for this compound in clinical trial records.