Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40

Exclusion Criteria

• •Active or history of peptic or gastric ulcer or hemorrhage
• •Any chronic major medical comorbid condition deemed by the Investigator as presenting added risk to the subject, including but not limited to refractory hypertension, kidney disease, or liver disease
• •Diagnosed with diabetes (Type 1 or II) or receiving any anti-diabetic medication
• •Unstable seizure disorder defined by any seizure within 6 months prior to baseline visit and/or a change in any anti-convulsant drug dosing in the 60 days prior to study entry
• •Patients with cardiovascular disease risk factors: Uncontrolled high blood pressure (systolic blood pressure \>150 mmHg), Unstable angina, History of documented myocardial infarction or cerebrovascular accident, NYHA Class III and IV heart failure, Known uncontrolled hyperlipidemia as LDL-C ≥190 mg/dL or triglycerides ≥ 500 mg/dL
• •Chronic use of NSAIDs or other anti-inflammatory agents
• •Currently taking or have taken any cannabidiol (CBD) preparation within 30 days prior to screening
• •Currently taking or have taken sulindac or gaboxadol within 30 days prior to screening
• •Currently taking GABAergic agents (i.e., acamprosate, baclofen, vigabatrin, tiagabine, riluzole, benzodiazepines, and gabapentin)
• •Changes in psychotropic or anti-convulsant (where taken for reasons other than seizure control) drug treatment within 30 days prior to Screening
• •Significant changes in any educational, behavioral and/or dietary interventions the month prior to Screening
• •Planned initiation of new, or modification of ongoing, interventions during the study
• •History of adverse effects of sulindac or other NSAIDs that would prevent safe study completion
• •Unable or unwilling to take oral medication (whole capsule) or history of dysphagia or malabsorption
• •Has abnormal baseline laboratory assessments including, but not limited to, ALT or AST or total bilirubin \>1.5 × ULN, or other clinically relevant laboratory abnormality
• •Has a clinically significant abnormal ECG, heart rate or BP at Screening as judged by the Investigator
• •Has received an investigational drug (either approved or not approved) in any prior clinical study within 30 days or 5 half-lives (whichever is longer) prior to Screening