Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-181 · 1 trial · 3 indications
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-...
ABBV-181 is an investigational small molecule being studied for the treatment of Human Immunodeficiency Virus (HIV), specifically HIV-1 infection. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
ABBV-181 targets PD-1, a protein involved in immune regulation. By modulating PD-1, the drug aims to alter immune responses in the context of HIV infection, though its exact therapeutic mechanism in this setting is still under investigation.
ABBV-181 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and effects in people with HIV.
ABBV-181 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. Its safety and efficacy are still being evaluated in early-stage clinical trials.
ABBV-181 has been studied in one completed Phase 1 clinical trial, identified as NCT04223804. This randomized, double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ABBV-181 in adult participants with HIV-1. The trial enrolled 41 participants across the United States, Australia, Canada, and Puerto Rico.
Yes, ABBV-181 is also known as budigalimab. In clinical trial records, the drug is referred to as ABBV-181 (Budigalimab), indicating that both names refer to the same investigational compound being developed by AbbVie.