Pharm-Olam was contracted to assess subcutaneous immunotherapy in adult and pediatric subjects with peanut allergy. The safety of the substance had already been confirmed in a First-In-Human (FIH) preliminary study. The research was critical in that there is no effective treatment for peanut allergies and there is a significant need.
The Phase I study population involved incremental dosing of three age groups across seven sites. Each cohort was randomized, double-blind, and placebo-controlled. Dosing was complex, but we overcame the challenge through agile study management.
Program Overview: Phase I
Indication: Evaluation of the safety and tolerability of a SCIT-treatment in adults, adolescents, and pediatric patients with peanut allergy.
