A phase I clinical study of the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-2106, an anti-CD40 antibody, following single intravenous or subcutaneous administration in healthy participants.

In 30 seconds

This Phase I randomized controlled trial evaluated the safety, pharmacokinetics, and pharmacodynamics of SHR-2106, an anti-CD40 antibody, in 51 healthy adults. The study found that SHR-2106 was well tolerated, with most adverse events being mild to moderate, and achieved over 80% CD40 occupancy within 24 hours.

Key findings

• SHR-2106 demonstrated a favorable safety profile, with treatment-emergent adverse events comparable to placebo.
• CD40 occupancy exceeded 80% within 24 hours across all doses.
• The geometric mean terminal half-life after intravenous administration ranged from 1.83 to 10.7 days.
• Absolute bioavailability after subcutaneous administration was approximately 60%.

Why it matters

Understanding the safety and pharmacokinetics of SHR-2106 is crucial for clinicians considering its potential use in immunotherapy, particularly in conditions requiring modulation of the immune response.