A Multi-Center, Randomized, Double-Blind, 12-Week, Parallel Group, Placebo-Controlled Proof of Concept Study to Investigate the Efficacy and Safety of RG7314 in Individuals With Autism Spectrum Disorders (ASD)

Placebo

RG7314

Change From Baseline in Social Communication Deficits as Measured by Social Responsiveness Scale 2 (SRS-2)

Percentage of Participants with Suicidality, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Percentage of Participants With Adverse Events

Change From Baseline in Behavior/Symptoms as Measured by Aberrant Behavior Checklist (ABC)

Change From Baseline in Behavior/Symptoms as Measured by Repetitive Behavior Scale-Revised (RBS-R)

Change From Baseline in Behavior/Symptoms as Measured by Anxiety, Depression and Mood Scale (ADAMS)

Measure: Change From Baseline in Behavior/Symptoms as Measured by State-Trait Anxiety Inventory (STAI)

Change From Baseline in Clinical Global Impressions as Measured by Clinical Global Impressions Improvement (CGI-I) Scale

Change From Baseline in Adaptive Functioning and Skills as Measured by Vineland-II Adaptive Behavior Scale (VABS)

Plasma Concentration of RG7314

Plasma Concentration of RG7314 Metabolite M3

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Concentration (AUClast) of RG7314

AUClast of RG7314 Metabolite M3

Maximum Observed Plasma Concentration (Cmax) of RG7314

Cmax of RG7314 Metabolite M3

Percentage of Participants With Clinical Response, Defined as At Least 25% Improvement in the SRS-2 Score With a CGI-I Score of 1 or 2