A Phase 1b/2, randomized, double-blind, placebo-controlled, multi-center study of STMC-103H in neonates and infants at risk for developing allergic disease
Objectives: Parts A1 & A2 Primary Objective The primary objective of Parts A1 and A2 of this study is to assess the safety and tolerability of STMC-103H in children and infant subjects at risk for development of allergic disease. Exploratory Objectives (Part A2 only) Exploratory objectives for Part A2 include stool metabolic profiling and stool microbiome analysis in STMC-103H in comparison to placebo in infant subjects. Part B Primary Objective The primary objective of Part B of this study is to assess the safety, tolerability, and preliminary efficacy of STMC-103H in neonate and infant subjects at risk for development of allergic disease. Preliminary efficacy will be assessed in Part B by the incidence of physician diagnosed atopic dermatitis at Day 336 in STMC-103H-treated subjects compared to placebo. Secondary Objectives In Part B, secondary objectives include evaluation of preliminary clinical efficacy and clinical biomarkers. Exploratory Exploratory objectives for Part B include assessment of immunologic biomarkers, stool metabolic profiling, and stool microbiome analysis in STMC-103H in comparison to placebo in neonate and infant subjects