NCT06126653

A Study to Evaluate ARD-501 in Patients With Autism Spectrum Disorder

A Blinded, Cross-Over Study to Evaluate the Safety and Efficacy of ARD-501 in Patients With Autism Spectrum Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Aardvark Therapeutics, Inc. · Industry
• Sex: All
• Age: 17 Years – 30 Years
• Healthy volunteers: Not accepted

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 0.2mg/kg, 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 1:1 ratio in two groups. Each group will be exposed to ARD-501 at 0.5mg/kg 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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Low Dose ARD-501	Titratable, liquid formulation, taken orally. The intervention is given relative to the body weight of the individual. 0.2 mg/kg dosing.
DRUG	High Dose ARD-501	Titratable, liquid formulation, taken orally. The intervention is given relative to the body weight of the individual. 0.5 mg/kg dosing.
DRUG	Placebo	Titratable, liquid formulation, taken orally.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-01-13
• Completion: 2025-01-13
• First posted: 2023-11-13
• Last updated: 2025-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study