Safety, Pharmacokinetics, and Pharmacodynamics of Single-Dose Programmed Cell Death Protein 1 Inhibitor, Budigalimab, in People With HIV-1 With Antiretroviral Therapy-Suppressed Viral Load.

In 30 seconds

This Phase 1b randomized controlled trial evaluated the safety, pharmacokinetics, and pharmacodynamics of single-dose budigalimab, a PD-1 inhibitor, in 32 people with HIV-1 on antiretroviral therapy. The study found an acceptable safety profile, with 22 participants reporting adverse events, primarily grade ≤2. The geometric mean maximum serum concentrations were 0.37, 1.57, and 3.2 µg/mL for the 10 mg SC, 20 mg SC, and 10 mg IV doses, respectively.

Key findings

• 22 out of 32 participants reported adverse events, mostly grade ≤2.
• Geometric mean maximum serum concentrations were 0.37, 1.57, and 3.2 µg/mL for different dosing regimens.
• PD-1 receptor saturation was ≥95% in most participants, lasting up to 42 days.

Why it matters

Understanding the safety and pharmacokinetics of PD-1 inhibitors like budigalimab is crucial for developing new therapeutic strategies in HIV treatment, particularly for enhancing immune responses.