MedTrace Logo

Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD

NCT06757504 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-05-14

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blind, multiple dose levels, parallal group, placebo-controlled study, to evaluate the safety, PK profiles and preliminary efficacy of TTYP01 tablets in adolescents and children with ASD.

Conditions

  • Autism Spectrum Disorder (ASD)

Interventions

DRUG

TTYP01 Tablets (12mg or 18mg)

Taken with a moderate amount of warm water or after disperse in a moderate amount of warm water, at least 60 minutes before breakfast and dinner.

DRUG

Placebo (Simulant TTYP01 Tablets)

Taken with a moderate amount of warm water or after disperse in a moderate amount of warm water, at least 60 minutes before breakfast and dinner.

Sponsors & Collaborators

  • Shanghai Auzone Biological Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jing Liu · Peking University Sixth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2026-02-06
Completion
2026-05-08

Countries

  • China

Study Locations

More Related Trials

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 NCT06757504 on ClinicalTrials.gov