None listed
Conditions
Interventions
Drug : Experimental 1: AST-001 High dose
Experimental 2: AST-001 Low dose
Comparator: Placebo of AST-001
Sponsors
Astrogen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ASD according to diagnostic and statistical manual of mental disorder(DSM)-5 criteria at screening, ASD diagnosis confirmed by Autism Diagnostic Interview-Revised(ADI-R) at screening period, Signed Informed Consent Form, Availability of a parent or other reliable caregiver who is fluent in Korean. The same person must agree to accompany the subject to all clinic visits and provide information about the subject's behavior and symptoms and must agree to oversee the subject's adherence with protocol-specified procedures and study medication dosing
Exclusion criteria
Exclusion criteria: Medical history, concomittant disease or operation history at screening, Uncontrolled medical condition including arrhythmia, cancer, severe heart/kidney disease at screening period, Causing Serious self-injury or harm to others that requires medical intervention during screening period, Children weighing over 60kg of body weight at screening, Inappropriate to participate in the trial determined by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| K-VABS-II (Korean-Vineland Adaptive Behavior Scale-II) | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI (Clinical Global Impression);SRS-2 (Social Responsiveness Scale-2);ABC (Aberrant Behavior Checklist);K-PSI-4-SF (Korean-Parenting Stress Index-4th Edition Short Form) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoo-Sook Joung
Samsung Medical Center
Outcome results
None listed