PRIME - PRotective IMmunostimulatory Evaluation

A Phase 1b, Randomized, Placebo Controlled, Single Blind, Single-Ascending Dose in Stage 3 and Stage 4 CKD Patients

Design

• Single dose, dose escalation

• 5 cohorts, 8 subjects per cohort 1:4 placebo vs drug (up to 40 patients)

• Follow for 7 days

Readouts

• Safety, tolerability, PK, and activity biomarkers

• Key biomarkers of activity: IL-10, IL-1RA, and TGF-b

• Demonstration of attenuated immune cell response to second stress

Status

• Study Initiated Jan 2025

• Topline data 1st half 2025