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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04799353 | Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV) | PHASE1 | COMPLETED | 33 | — | — | Mar 15, 2021 | Oct 11, 2022 | Oct 17, 2022 | 10 | 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 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 \[which utilizes the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale\] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.
Maximum Serum Concentration (Cmax) of Budigalimab.
Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
Area Under the Plasma Concentration-time Curve (AUC).
Terminal phase elimination half-life (t1/2)
| Arm | Type | Description |
|---|---|---|
| Group 1: Placebo SC + Placebo IV | EXPERIMENTAL | Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo. |
| Group 2: Budigalimab (SC) + Placebo IV | EXPERIMENTAL | Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. |
| Group 3: Budigalimab SC + Placebo IV | EXPERIMENTAL | Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. |
| Group 4: Placebo SC + Budigalimab IV | EXPERIMENTAL | Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab. |
| Name | Type | Description |
|---|---|---|
| Budigalimab | DRUG | Subcutaneous (SC) |
| Placebo | DRUG | Subcutaneous (SC) |
Inclusion Criteria: * Condition of generally good health, body mass index ≥ 18.0 to \< 35.0 kg/m2. * Laboratory values must meet acceptable criteria. * Human Immunodeficiency Virus (HIV-1) infected on antiretroviral therapy (ART) for at least 12 months prior to screening and on current ART regimen ...