Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Low Dose ARD-501 · 1 trial · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| Phase 1: Low Dose | EXPERIMENTAL | ARD-501 for 7 days at 0.2 mg/kg |
| Phase 2: Placebo | PLACEBO_COMPARATOR | Placebo for 7 days |
| Phase 2: High Dose | EXPERIMENTAL | ARD-501 for 7 days at 0.5 mg/kg |
| Phase 2: Crossover Placebo to High Dose | EXPERIMENTAL | ARD-501 for 7 days at 0.5 mg/kg |
| Phase 2: Crossover High Dose to Placebo | PLACEBO_COMPARATOR | Placebo for 7 days |
| Name | Type | Description |
|---|---|---|
| Low Dose ARD-501 | DRUG | Titratable, liquid formulation, taken orally. The intervention is given relative to the body weight of the individual. 0.2 mg/kg dosing. |
| High Dose ARD-501 | DRUG | Titratable, liquid formulation, taken orally. The intervention is given relative to the body weight of the individual. 0.5 mg/kg dosing. |
| Placebo | DRUG | Titratable, liquid formulation, taken orally. |
Inclusion Criteria: Subjects must meet all the following criteria to be eligible for participation in this study: * Male and female subjects, 17-30 years of age * Able and willing to sign consent and comply with study protocol * Diagnostic confirmation of ASD as confirmed by gold standard clinical...
Low Dose ARD-501 is an investigational small molecule being developed for the treatment of Autism Spectrum Disorder. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
The specific molecular target of Low Dose ARD-501 has not been disclosed. It is a small molecule being studied for its potential effects in Autism Spectrum Disorder, but its mechanism of action is not publicly detailed.
Low Dose ARD-501 is being developed by Aardvark Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol AARD.
Low Dose ARD-501 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. A Phase 2 clinical trial has been completed to evaluate its safety and efficacy.
Low Dose ARD-501 has been studied in one completed Phase 2 clinical trial, identified as NCT06126653. This randomized, double-blind, placebo-controlled trial enrolled 5 participants with Autism Spectrum Disorder in the United States.
Yes, Low Dose ARD-501 is the same drug as ARD-501. The term 'Low Dose' refers to the specific dosage strength being evaluated in clinical trials, but the active pharmaceutical ingredient is identical.