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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scioto Biosciences, Inc.

Criteria

Inclusion Criteria:

• Subject/parent (or authorized designee) has provided written informed consent for the study.

• Subject is ≥15 and ≤45 years of age at the time of enrollment.

• Diagnosis of autistic disorder (AD) as confirmed by the gold standard clinical interview using Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria and administration of the Autism Diagnostic Observation Schedule-2.

• Subject, if female and of childbearing potential, is not lactating or pregnant.

• Subject, if female, is either not of childbearing potential or is practicing an acceptable effective method of birth control.

• Subject is willing to comply with all study requirements (including the requirements for stool sampling and biobanking) and to return to the study facility for the follow-up evaluations, as required.

Exclusion Criteria:

• Subject has known allergy or significant adverse reaction to L reuteri, Sephadex®, maltose, or related compounds.

• Subject has previously had GI surgery, intestinal obstruction, Clostridium difficile infection or diverticulitis.

• Subject has travelled outside of the USA in the 30 days prior to screening.

• Subject has had a diarrheal illness in 30 days prior to screening.

• Subject currently has a fever or active/uncontrolled gastrointestinal (GI) symptoms (e.g., nausea, vomiting, diarrhea, constipation, abdominal distention, abdominal pain/cramps, flatulence) or has had these within 14 days prior to screening. If the GI symptoms are stable, in the opinion of the investigator, the subject can be enrolled.

• Subject has any immunological/autoimmune disorder including, but not limited to, systemic lupus erythematosis, rheumatoid arthritis, Sjögren's syndrome, inflammatory bowel disease, or immunoglobulin-deficiency disorder, that would increase the risk to the subject or interfere with the evaluation of SB-121.

• Subject has a documented history of human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C

• Subject has implanted prosthetic devices including prosthetic heart valves.

• Subject has taken, or is taking, any of the following prohibited medications:

1. A proton pump inhibitor within 2 weeks prior to screening

2. Use of supplemental probiotics within 2 weeks prior to screening except for yogurt

3. Current use of immunosuppressive medications, including corticosteroids

4. Treatment with monoclonal antibodies within 4 weeks prior to screening

5. Systemic antibiotics within 2 weeks prior to screening

• Subject has diabetes mellitus or is prediabetic.

• Subject has received any IP (or investigational device) within 30 days prior to screening.

• Subject has any of the following laboratory test results at Screening:

1. An absolute neutrophil count of <1.5 × 10^9/L

2. alanine aminotransferase or aspartate aminotransferase >1.5 × upper limit normal (ULN), total bilirubin >1.5 × ULN (subjects with known Gilbert's Syndrome can be included)

3. serum creatinine >1.5 × ULN

4. any other abnormal laboratory test that is clinically significant in the judgment of the investigator.

• Subject has an unstable medical condition or is otherwise considered unreliable or incapable, in the opinion of the investigator, of complying with the requirements of the protocol.

• Subject tests positive for drugs of abuse in a urine drug screen at screening.

• Subject has a history of alcohol abuse.