Trial on Single/Multiple Ascending Doses for Safety, PK and PD for CBP-0276 in Healthy Subjects

Exclusion criteria

• . Pregnant or breastfeeding women.
• . History of cardiac, endocrine, gastrointestinal, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric or renal disease clinically significant or comorbidity of importance at the discretion of the Principal Investigator (or his/her delegate).
• . History of allergic reactions, anaphylactic reactions, severe systemic hypersensitivity, or any allergic reaction that, in the opinion of the Principal Investigator or his/her delegate, is likely to be exacerbated by the investigational product.
• . History of malignant or ongoing disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely removed and are considered cured at least 1 year before day 1 \[first period, when applicable\]).
• . Systolic blood pressure in the supine position \< 90 mmHg, \>140 (18 to 59 years) or \>160 (≥ 60 years); diastolic blood pressure \> 90 or \< 50 mmHg, heart rate \>100 or \< 40 beats per minute. Orthostatic decrease in systolic blood pressure \>20 mmHg, orthostatic decrease in diastolic blood pressure \>10 mmHg, or orthostatic increase in heart rate \> 30 beats per minute. If any of the parameters are out of range, the measurements should be repeated two more times. Subjects will be excluded if the average of the 3 measurements is outside the corresponding reference range.
• . Clinically significant abnormalities (at the discretion of the Principal Investigator or his/her delegate) in the 12-lead electrocardiogram. QT interval corrected using Fridericia's correction method, QTcF \> 450 ms for men and \> 470 ms for women.
• . Elective procedures or surgeries scheduled after signing the Informed Consent Form and until the end-of-study visit.
• . History of gastric bypass/bariatric surgery or other gastrointestinal surgery that may affect gastric emptying or absorption of RAP-103 (excluding uncomplicated appendectomy and hernia repair performed at least 90 days prior to the screening visit).