A Phase 1, Randomized, Double-Blind, Two-Arm, Placebo-Controlled, Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of LJPC-401 in Healthy Adults

Single and multiple doses of LJPC-401 delivered subcutaneously by site staff. Ascending-dose cohorts at 4 mg, 10 mg, and 20 mg per dose in single-dose cohorts. One dose cohort at 10 mg per dose administered twice weekly for two weeks in a multiple-dose cohort (Days 1, 4, 8 and 11). A Data Monitoring Committee (DMC) comprised of the Principal Investigator (PI), the Sponsor’s medical representatives, and other site, sponsor, and contract research organization representatives, as applicable, to include at least one independent member, met prior to the start of the multiple-dose cohort to review all treatment-emergent adverse events (TEAEs), and to make study-related decisions (i.e. escalation, dose level, etc.). The DMC met after the last subject in the single-dose cohorts had completed their Day 8 visit. The proposed doses had been tested in two previous clinical studies and were below the maximum tested dose of 30 mg. The DMC was also responsible for making study decisions regarding stopping, interrupting subject recruitment, or expanding enrollment in the study or cohort based upon review of the study data.