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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04223804 | A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1 | PHASE1 | COMPLETED | 41 | — | — | Jan 30, 2020 | Feb 27, 2023 | Mar 9, 2023 | 23 | United States, Australia +2 |
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 the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.
Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines (which utilizes the NIH CTCAE grading scale) but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.
Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome.
Maximum Observed Concentration (Cmax) of ABBV-181.
Time to Cmax (Tmax) of ABBV-181.
Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.
Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181.
Half-life (t1/2) of ABBV-181 following the last dose.
| Arm | Type | Description |
|---|---|---|
| Stage 1: Arm A | PLACEBO_COMPARATOR | Participants will receive placebo. |
| Stage 1: Arm B | EXPERIMENTAL | Participants will receive ABBV-181 dose A. |
| Stage 1: Arm C | EXPERIMENTAL | Participants will receive ABBV-181 dose B. |
| Stage 2: Arm D | PLACEBO_COMPARATOR | Participants will receive Placebo. |
| Stage 2: Arm E | EXPERIMENTAL | Participants will receive ABBV-181 dose C. |
| Name | Type | Description |
|---|---|---|
| ABBV-181 | DRUG | Intravenous (IV) Infusion |
| Placebo | DRUG | Intravenous (IV) infusion |
Inclusion Criteria: * Body Mass Index (BMI) between 18.0 and 35 kg/m2. * HIV-1 infected on antiretroviral therapy (ART) for at least 12 months prior to screening and on current ART regimen for at least 8 weeks prior to screening. * Meets HIV-specific laboratory parameters as below: * Plasma HIV-...