RecruitingPhase 2NCT06757504

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

A Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-controlled Phase II Trial of TTYP01 Tablets in Adolescents and Children With Autism Spectrum Disorders


Sponsor

Shanghai Auzone Biological Technology Co., Ltd.

Enrollment

150 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo (Simulant TTYP01 Tablets) and a drug called TTYP01 Tablets (12mg or 18mg) for people with autism spectrum disorder (asd). The study is currently recruiting participants at 5 locations. People eligible for this study include aged 6 Years to 16 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTTYP01 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.

DRUGPlacebo (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.


Locations(5)

Peking University Sixth Hospital

Beijing, China

The Second Xiangya Hospital of Central South University

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

Nanjing Brain Hospital, The Affiliated Brain Hospital of Nanjing Medical University

Nanjing, China

Tianjin Mental Health Center

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT06757504


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