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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06126653
Recruitment Status : Recruiting
First Posted : November 13, 2023
Last Update Posted : January 18, 2024
Sponsor:
Collaborator:
Center for Psychiatry And Behavioral Medicine Inc.
Information provided by (Responsible Party):
Aardvark Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Low Dose ARD-501 Drug: High Dose ARD-501 Drug: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a blinded, placebo controlled, cross-over trial
Masking: Double (Participant, Investigator)
Masking Description: Double blinded
Primary Purpose: Treatment
Official Title: A Blinded, Cross-Over Study to Evaluate the Safety and Efficacy of ARD-501 in Patients With Autism Spectrum Disorder
Estimated Study Start Date : January 30, 2024
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1: Low Dose
ARD-501 for 7 days at 0.2 mg/kg
 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.
Placebo Comparator: Phase 2: Placebo
Placebo for 7 days
 Drug: Placebo
Titratable, liquid formulation, taken orally.
Experimental: Phase 2: High Dose
ARD-501 for 7 days at 0.5 mg/kg
 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.
Experimental: Phase 2: Crossover Placebo to High Dose
ARD-501 for 7 days at 0.5 mg/kg
 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.
Placebo Comparator: Phase 2: Crossover High Dose to Placebo
Placebo for 7 days
 Drug: Placebo
Titratable, liquid formulation, taken orally.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the incidence of Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Baseline to Week 5 ]
    To measure the efficacy evaluation of safety in subjects with autism spectrum disorder (ASD) by assessment of the incidence of Treatment-Emergent Adverse Events (TEAE).


Secondary Outcome Measures :
  1. Assessment of change in the Clinical Global Impression - Severity/Improvement (CGI-S/I) scale [ Time Frame: Baseline to Week 5 ]
    To evaluate efficacy in subjects with ASD on the Clinical Global Impression - Severity/Improvement (CGI-S/I) scale

  2. Assessment of change on the Social Responsiveness Scale, Second Edition (SRS™-2, version-adjusted for age) [ Time Frame: Baseline to Week 5 ]
    To evaluate efficacy in social responsiveness in subjects with ASD on the Social Responsiveness Scale, Second Edition (SRS™-2, version-adjusted for age).


Other Outcome Measures:
  1. Assessment of change in Gastrointestinal Severity Index (GSI) [ Time Frame: Baseline to Week 5 ]
    To evaluate the efficacy of improvement in the gastrointestinal severity as assessed by the Gastrointestinal Severity Index (GSI)

  2. Assessment of change in Pain Detection Threshold (PDT) and Pain Tolerating Threshold (PTT) as measured during the Cold Pressor Test [ Time Frame: Baseline to Week 5 ]
    To evaluate efficacy of improvement or change in Pain Detection Threshold (PDT) and Pain Tolerating Threshold (PTT) as measured during the Cold Pressor Test

  3. Assessment of change on the Adaptive Behavior Assessment System (ABAS-3) [ Time Frame: Baseline to Week 5 ]
    To evaluate efficacy in adaptive behavior as assessed by change in the Adaptive Behavior Assessment System (ABAS-3)


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all the following criteria to be eligible for participation in this study:

  • Male and female subjects, 17-25 years of age
  • Able and willing to sign consent and comply with study protocol
  • Diagnostic confirmation of ASD as confirmed by gold standard clinical interview using Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria and administration of the Autism Diagnostic Observation Schedule-2, Module 3 or 4.
  • A minimum score of greater or equal to 76 or greater in the SRS™-2 (version-adjusted for subject's age bracket)
  • General good health as determined by physical exam, medical and psychiatric history and safety labs as defined by the Principal Investigator or designee.
  • Male study participants who are sexually active with a female partner of childbearing potential must be surgically sterilized, or agree to use highly effective methods of birth control (defined below), and not rely on barrier methods and spermicide alone, from the time of screening until 1 week after final dose of study drug.
  • Female participants of childbearing potential may be included in the study provided that they choose an effective contraception method that: 1) is not user dependent as permanent sterilization, intrauterine devices, and implants); or 2) is a user dependent short-acting hormonal method of contraception (e.g.injection, oral, transdermal, and intravaginal).

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from study participation:

  • Allergy or hypersensitivity to ARD-501.
  • Inability to swallow study drug.
  • Unstable dosing of any mood, anxiety or behavior medications in 4 weeks prior to baseline visit.
  • Concomitant use of scheduled benzodiazepines, baclofen, gabapentin, pregabalin, or supplements with impact on the γ-aminobutyric acid (GABA) system.
  • Concomitant use of any cannabinoid or related product.
  • Any use of opioid medication
  • Unstable seizure disorder as defined by any seizure in the 6 months prior to baseline visit and/or a change in any anti-convulsant drug dosing in the 60 days prior to study screen.
  • Abnormal baseline safety lab assessments including, but not limited to alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than 1.5x the upper limit of normal, total bilirubin or creatinine greater than 1x the upper limit of normal, other clinically relevant lab abnormality, or abnormality in electrocardiogram (ECG), heart rate (HR), or blood pressure (BP) at screening as determined by the investigator or designee.
  • History of or current abuse of drugs or alcohol including prescription medication.
  • Women who are pregnant (i.e., have a positive pregnancy test), intending to become pregnant, breast feeding, or women of child-bearing potential who are unwilling to use contraception as required in the study inclusion criteria or maintain abstinence during the course of the study
  • Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study
  • History of major depressive disorder or history of other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
  • Suicidal ideas and behavior as assessed by the Columbia suicide severity scale (C-SSRS)
  • Consumption of more than 2 units (males) or 1 unit (females) per day of alcohol during the study
  • Any condition(s), including psychiatric disorders such as, but not restricted to bipolar disorders, that the investigator or primary physician believes may not be appropriate for participating the study
  • Patients weighing more than 275 lb (124.7 kg)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06126653


Contacts
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Contact: Andreas Niethammer, MD PhD +1 (858) 225 7696 AndreasNiethammer@aardvarktherapeutics.com
Contact: Alexa M Warner, BSc 616-337-0224 Alexa@aardvarktherapeutics.com

Locations
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United States, Nevada
Center for Psychiatry and Behavioral Medicine Inc Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Allison Buen    702-838-0742    abuen.cpbm@gmail.com   
Sponsors and Collaborators
Aardvark Therapeutics, Inc.
Center for Psychiatry And Behavioral Medicine Inc.
Investigators
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Principal Investigator: Ann Childress, MD Center for Psychiatry and Behavioral Medicine
More Information
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Responsible Party: Aardvark Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06126653    
Other Study ID Numbers: AARD-501.2
First Posted: November 13, 2023    Key Record Dates
Last Update Posted: January 18, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aardvark Therapeutics, Inc.:
Autism
High Opioid Tone
ASD
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders