NCT06951854

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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Neuroventi Inc. · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, therapeutic exploratory Phase 2 clinical trial designed to evaluate the efficacy and safety of NV01-A02 in pediatric participants diagnosed with Autism Spectrum Disorder (ASD).

Conditions

• Autism Spectrum Disorder (ASD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-09-01
• Completion: 2026-12-01
• First posted: 2025-04-30
• Last updated: 2025-04-30

Locations

1 site across 1 country: South Korea