Overview

28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder

Status:
Recruiting
Trial end date:
2022-04-30
Target enrollment:
Participant gender:
Summary
SB-121 is being developed for use in the treatment of autistic disorder (AD). This study is a multiple-dose, randomized, double-blind, placebo-controlled, cross-over single-site Phase I study. The primary objective is to evaluate the safety and tolerability of multiple doses of SB-121 in subjects ages 15 to 45 years with AD. Additionally, multiple measures of AD, as well as mechanistic biomarkers, will be assessed in order to inform later stage trials.
Phase:
Phase 1
Details
Lead Sponsor:
Scioto Biosciences, Inc.