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 being developed by AbbVie Inc. and is currently in Phase 1 clinical development.
ABBV-181 targets PD-1, a protein involved in immune regulation. By targeting PD-1, the drug aims to modulate the immune response in the context of HIV infection. This mechanism is being evaluated in clinical trials for its potential role in treating HIV.
ABBV-181 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. The drug is currently in Phase 1 clinical development for the treatment of HIV.
ABBV-181 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial evaluating the drug in adult participants with HIV-1 has been completed.
ABBV-181 has been evaluated in one clinical trial with the identifier NCT04223804. This Phase 1 study assessed the safety, pharmacokinetics, and pharmacodynamics of ABBV-181 in adult participants with HIV-1. The trial was completed and enrolled 41 participants.
Yes, ABBV-181 is also known as budigalimab. The clinical trial NCT04223804 refers to the drug as ABBV-181 (Budigalimab), confirming that these names refer to the same investigational drug being developed by AbbVie Inc.