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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Scioto Biosciences, Inc. · Industry
• Sex: All
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autistic Disorder

Interventions

Type	Name	Description
DRUG	SB-121	SB-121 is a formulation of L. reuteri
DRUG	Placebo	Placebo oral formulation

Timeline

• Start date: 2021-08-02
• Primary completion: 2022-03-03
• Completion: 2022-03-03
• First posted: 2021-06-30
• Last updated: 2024-03-25
• Results posted: 2024-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study