A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101)

A Phase I, Single and Multiple Ascending Dose Escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Subjects

A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers.

Primary Objectives:

● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers,

Secondary Objectives:

• To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers;
• To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers;
• To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;

Inclusion Criteria:

• Male or female healthy voluteers
• Aged 18-45 years(inclusive),
• In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose.

Exclusion Criteria:

• Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception.
• Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia.
• Positive screening for HIV, Hepatitis B/C or syphilis;
• Recent subject in another clinical trial;
• Recent major surgery, or significant blood loss.