clinical trial · NCT04944901
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
Scioto Biosciences, Inc.·phase1·completed·n = 15
Autistic DisorderSB-121Placebo
brief 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.
started
Aug 2, 2021
primary completion
Mar 3, 2022
completion
Mar 3, 2022
last updated
Mar 25, 2024
official title
Randomized, Double-blind, Placebo-controlled, 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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol