Safety, tolerability, and pharmacokinetics/-dynamics of the dipeptidyl peptidase 3-inhibiting antibody Procizumab in a first-in-human trial.
Dirk van Lier, Louis Mourisse, Hákon Hollander et al.
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In 30 seconds
This Phase 1 randomized controlled trial evaluated the safety, tolerability, and pharmacokinetics of Procizumab (PCZ), a DPP3-inhibiting antibody, in 24 healthy male volunteers. The study found that adverse events were predominantly mild, with no serious adverse events reported. PCZ demonstrated a terminal elimination half-life of 24, 34, and 53 hours across different doses.
Key findings
- Adverse events associated with PCZ were predominantly mild, with no serious adverse events reported.
- PCZ exhibited a terminal elimination half-life of 24, 34, and 53 hours for low, intermediate, and high doses, respectively.
- The volume of distribution of PCZ was approximately 9.8-10.2 liters, indicating it remains primarily in circulation.
Why it matters
Understanding the safety and pharmacokinetics of new therapies like Procizumab is crucial for clinicians, especially in managing conditions like cardiogenic shock where DPP3 plays a role in hemodynamic stability.