Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China

Inclusion criteria

• Males and female participants between 18-45 years (Both inclusive);
• Body weight≥50kg.Body mass index (BMI) 18~28 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
• Participants who voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.

Exclusion criteria

• Any clinically significant abnormality upon physical examination or in the clinical laboratory tests. History or presence of a clinically significant gastrointestinal, renal, hepatic, neurologic, hematic, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular disorder(s) (but not limited to above disorders).
• Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ,treponema pallidum antibodies at screening.
• Participants who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.
• Participants who have undergone surgery within 6 months before the screening period or whose surgical incision is not completely healed; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, or an open biopsy or significant traumatic injury;
• Workers engaged in conditions requiring long-term exposure to radioactivity; Or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before this study or have participated in the radiopharmaceutical labeling test;
• Participants who smoked an average of >5 cigarettes per day in the previous 3 months or habitually used nicotine-containing products and were unable to quit during the trial period;
• Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, etc.) in the 1 year prior to the screening period; Or screening for positive urine drug abuse (drug) tests;
• Participants who have special dietary requirements and cannot comply with a uniform diet;
• History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to RAY1216 or any of the ingredients of its formulation or similar drugs.