NCT06951854View on ClinicalTrials.gov

Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder

PHASE2RecruitingINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

September 1, 2025

Study Completion Date

December 1, 2026

Conditions
Autism Spectrum Disorder (ASD
Interventions
DRUG

Drug: NV01-A02

NV01-A02 will be administered orally at a different dose once daily for 8 weeks. The formulation is a white, film-coated tablet, designed for use in patients with mild to moderate cognitive impairment.

DRUG

Drug: Placebo (ZP8396)

ZP8396 is a matching placebo tablet administered orally once daily for 8 weeks. The placebo is identical in appearance to NV01-A02 but contains no active ingredient.

Trial Locations (1)

06100

RECRUITING

Neuroventi, Seoul

All Listed Sponsors
lead

Neuroventi Inc.

INDUSTRY