At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
SB-121 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating SB-121 and Placebo for Autistic Disorder. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutistic Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedJun 2021
Enrollment StartAug 2021
Primary CompletionMar 2022
TodayJul 2026
First PostedJun 30, 2021
Enrollment StartAug 2, 2021
Primary CompletionMar 3, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.0 years ago
Interventions
SB-121drug
SB-121 is a formulation of L. reuteri
Placebodrug
Placebo oral formulation