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

Launched by SHANGHAI AUZONE BIOLOGICAL TECHNOLOGY CO., LTD. · Jan 2, 2025

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ClinConnect Summary

This clinical trial is looking at a new medication called TTYP01 in children and adolescents with Autism Spectrum Disorder (ASD). The goal is to find out how safe the medication is and how well it might help improve symptoms of ASD. The study is being conducted at multiple sites and is designed to compare TTYP01 to a placebo, which is a pill that looks the same but doesn’t contain any active medication. Participants will be randomly assigned to receive either TTYP01 or the placebo, and they will take the tablets for a certain period of time.

To be eligible for this trial, participants need to be between the ages of 6 and 15 years old and have a confirmed diagnosis of ASD. They should also meet specific criteria related to their condition, such as a certain score on an autism assessment tool. It's important that participants and their guardians understand the trial and agree to take part. Throughout the study, participants will be monitored closely for any side effects and to see how well the medication works. If you think your child might qualify and you want to learn more, it would be a good idea to discuss this with their doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants are eligible for the study only if all of the following inclusion criteria are met:
• • 1. Aged ≥ 6 to \<16 years at the time of signing the ICF (age \<16 years after 12-week treatment), including adolescents aged ≥ 12 to\<16 years at the time of signing the ICF (age \<16 years after 12-week treatment), and children aged ≥ 6 to\<12 years at the time of signing the ICF;
• • 2. Male or female;
• • 3. Participants diagnosed with ASD according to the ASD diagnostic criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and confirmed by the Schedule for Affective Disorders and Schizophrenia for School Aged Children Present and Lifetime version (K-SADS-PL), DSM-5 ASD module;
• • 4. Child Autism Rating Scale 2-ST (CARS 2-ST) raw score ≥36;
• • 5. CGI-S score ≥4;
• • 6. Participants and their legal guardians understand and are willing to participate in this trial, with ICF signed by the legal guardian and participants aged ≥ 8 years; for participants who, at the discretion of the investigator, have cognitive deficits that prevent them from signing the ICF, their legal guardians sign the ICF on behalf of them;
• • 7. Females of childbearing potential (as defined in Appendix 15.1) agree to remain abstinent or use a reliable method of contraception for the duration of the trial and until 3 months after the last dose of the investigational product.
• Exclusion Criteria:
• Any participant who meets any of the following criteria will be excluded:
• • 1. Weight \<20.0 kg or \>70.0 kg, or BMI ≥35.0 kg/m\^2;
• • 2. Pregnant or lactating women;
• • 3. Presence of a serious mental disorder as assessed by the investigator, e.g., schizophrenia, bipolar disorder, depressive disorder, etc.; the presence of significant anxiety, tension, agitation, fear, depression, or the presence of suicidal risk, significant risk of self-injury, impulsivity, aggression, or behaviors based on the medical history and the routine mental status examination;
• • 4. History of epileptic seizures within 3 months prior to screening, or presence of a history of severe physical or neurological disease, history of severe head trauma;
• • 5. Participants with a history or symptoms of other mental illness that, at the discretion of the investigator, may affect the results of the study;
• • 6. Participants with a history of any unstable physical or neurological condition or currently suffering from a physical or neurological condition that, at the discretion of the investigator, may put them at risk of a significant adverse event or interfere with the assessment of safety and efficacy during the course of the trial;
• • 7. Pre-existing educational training and/or behavioral treatments fail to be stabilized prior to screening and consistent throughout the trial;
• • 8. Participants who are unable to discontinue or may use other treatments during the screening period and throughout the trial due to their condition, including: antipsychotic medications (except those that may be used in combination during the trial as specified in the protocol), medications that may have a therapeutic effect on ASD, nootropic drugs, medications for ADHD, intestinal flora modification, and other intestinal flora modification supplementation alternatives;
• • 9. Participants who have used treatment modalities such as transcranial magnetic stimulation therapy, direct current stimulation therapy, electroencephalographic biofeedback therapy, auditory integration training, executive function training, acupuncture therapy, etc., within 2 months prior to randomization, or may use such treatments during the treatment period;
• • 10. 12-ECG and laboratory results as outlined below: (1)QTc is outside the normal range of the site; (2)Platelets are below the lower limit of normal for the site; (3)Haemoglobin is below the lower limit of normal for the site; (4)Neutrophil count is below the lower limit of normal for the site; (5)ALT or AST ≥ 2 × upper limit of normal, or total bilirubin \> upper limit of normal for the site; (6)Urea nitrogen or creatinine is above the upper limit of normal for the site; (7)Any other abnormal laboratory, vital sign, or 12-ECG findings that, at the discretion of the investigator, are abnormal and clinically significant and will affect the safety of the participant or the interpretation of the study results;
• • 11. Participation in any clinical trial of a drug or non-drug intervention within the last 1 month;
• • 12. Concomitant medications/therapies that are prohibited in the protocol may be required during the trial;
• • 13. Participants expected to undergo elective surgery during the trial;
• • 14. Participants whose parents/guardians are unable to understand and/or complete the scale assessments in this trial.
• • 15. Hypersensitivity to edaravone and excipients (Soluplus, sodium bisulphite, microcrystalline cellulose, magnesium stearate, polyvinylpolypyrrolidone) in TTYP01 tablets;
• • 16. Participants who are judged by the investigator to be ineligible for other reasons.