NCT04895215.

Study name	A three‐arm, parallel group, randomized, double‐blind, placebo‐controlled study of the efficacy, safety, and tolerability of AB‐2004 in a 13 to 17 year‐old autism spectrum disorder population
Methods	8‐week parallel trial of two doses of AB‐2004 versus placebo
Participants	Inclusion criteria: clinically diagnosed, documented ASD DSM‐5 criteria ABC‐I score ≥ 18 at the screening visit CGI‐S scale score ≥ 4 at the screening visit Exclusion criteria: use of an oral, injected, or inhaled antibiotic within 30 days prior to screening. Prophylactic oral antibiotic use of no more than 1 dose will be permitted current use of an oral controlled or extended‐release medication have a comorbid major psychiatric condition (e.g. schizophrenia or bipolar disorder) at screening that in the opinion of the Investigator may interfere with the participant's ability to complete study procedures/comply with study requirements current use of antipsychotics (eg, aripiprazole or risperidone) Setting/location: "13 sites in the U.S., and two sites in Australia/New Zealand combined." Sample size: target sample size is 195
Interventions	Intervention: AB‐2004 (high‐dose) taken 3 times daily; or AB‐2004 (low‐dose) taken 3 times daily Comparator: equivalent placebo taken 3 times daily
Outcomes	Primary outcomes: mean change in ABC‐I score (Aman 1985) from baseline to endpoint AEs Secondary outcomes: none reported Timing of outcome assessments: baseline and endpoint (week 8)
Starting date	August 2021
Contact information	Name:Jeffrey Young E‐mail: jeffrey@axialtx.com
Notes	Source of funding: details not reported Conflicts of interest: not reported