Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults

Exclusion criteria

• . Females who are pregnant, planning to become pregnant, or breastfeeding during the trial or within 3 months after the trial, or those with abnormal pregnancy test results that are clinically significant at Screening or Baseline (Day -1) as judged by the investigator;
• . Has a positive alcohol test at Screening or the Baseline, or has a history of alcohol abuse;
• . Participants who have been drinking excessive amounts of tea, coffee or caffeinated drinks (more than 8 cups a day, 1 cup =250 mL) per day within 3 months before Screening;
• . Currently uses tobacco, nicotine or tobacco products, e-cigarettes or has stopped using tobacco products within the past 3 months and/or has a positive urine cotinine test at Screening or Baseline;
• . Positive urine screening for drug abuse;
• . Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to the first dose of study drug, or plan to receive another experimental agent during the duration of this trial;
• . Positive test result for active infectious diseases screening at Screening or Baseline, including human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, and syphilis antibody (TP);
• . Serious infection within 1 months before Screening or symptoms of infection during Screening period, including acute and chronic infections and local infections (bacterial, viral, parasitic, fungal, or other opportunistic pathogens), which is inappropriate to participant as deemed by the investigator;