None listed
Conditions
Interventions
Drug : Main study(0~12 weeks)
Experimental: AST-001
Comparator: Placebo of AST-001
Extension study(12~24 weeks)
Experimental: AST-001
Comparator: AST-001
Sponsors
Astrogen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those who meet the criteria of diagnostic and statistical manual of mental disorder (DSM)-5 during screening, During screening period, individuals who are diagnosed with ASD through ADI-R assessment, Subject with a CGI-S score of 4 or higher as a result of Clinical Global Impression(CGI) evaluation during baseline visit(visit 2), Subject or/and legally authorized representative voluntarily agreed to participate in this clinical trial and provided their informed consent by signing the written consent form, In case of subjects who were receiving non-pharmacological therapy at the time of screening, the non-pharmacological therapy lasted at least 3 months prior to participation in screening and is expected to be sustainable during this clinical trial, Subject whose legally authorized representative is able to participate in the provision of reliable information about the subject’s condition, execute all scheduled site visits, oversee IP administration, fully understand and speak Korean, and conduct survey evaluation regarding the subject
Exclusion criteria
Exclusion criteria: At the time of screening, subject has the medical history, concomitant condition, or surgical history, During the screening period, uncontrolled medical conditions, During the screening period, display of severe self-harm or injury to others that requires medical treatment, determined by investigator, At the time of screening, weight over 60kg, 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);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