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

NCT06126653 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-05-09

No results posted yet for this study

Summary

This is a blinded, placebo controlled, cross-over trial evaluating the safety of two dose-levels of ARD-501 in subjects with ASD.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Center for Psychiatry And Behavioral Medicine Inc.

    collaborator INDUSTRY

  • Aardvark Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
17 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-01-13
Completion
2025-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126653 on ClinicalTrials.gov