Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126653
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-10-20
Brief Title:
A Study to Evaluate ARD-501 in Patients With Autism Spectrum Disorder
Sponsor:
Aardvark Therapeutics Inc
Organization:
Aardvark Therapeutics Inc
Study Overview
Official Title:
A Blinded Cross-Over Study to Evaluate the Safety and Efficacy of ARD-501 in Patients With Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a blinded placebo controlled cross-over trial evaluating the safety of two dose-levels of ARD-501 in subjects with ASD
Detailed Description:
This study is a blinded placebo controlled cross-over trial evaluating the safety and efficacy of two dose levels in subjects with Autism Spectrum Disorder
A total of up to 12 subjects will be enrolled in the clinical study
A screening process will be initiated upon completion of the informed consent process Subjects will be assessed for eligibility through screening tests conducted within 28 days prior to enrollment Following completion of screening tests and confirmation of eligibility subjects will be enrolled to complete pre-dosing requirements and questionnaires during screening window as per protocol
There are two phases In Phase 1 all patients will be given ARD-501 at 02mgkg dependent on their body weight BW for 7 days followed by a 7-day washout period Subsequently in Phase 2 patients will be blinded and randomized at a 11 ratio in two groups Each group will be exposed to ARD-501 at 05mgkg BW and placebo in alternate order Each dosing week is followed by a 7-day washout
All available safety and tolerability data will be evaluated throughout study conduct
A total of up to 12 subjects will be enrolled in the clinical study
A screening process will be initiated upon completion of the informed consent process Subjects will be assessed for eligibility through screening tests conducted within 28 days prior to enrollment Following completion of screening tests and confirmation of eligibility subjects will be enrolled to complete pre-dosing requirements and questionnaires during screening window as per protocol
There are two phases In Phase 1 all patients will be given ARD-501 at 02mgkg dependent on their body weight BW for 7 days followed by a 7-day washout period Subsequently in Phase 2 patients will be blinded and randomized at a 11 ratio in two groups Each group will be exposed to ARD-501 at 05mgkg BW and placebo in alternate order Each dosing week is followed by a 7-day washout
All available safety and tolerability data will be evaluated throughout study conduct
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None