Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants

A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)

The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:

• Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study.
• Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study.
• Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.

Inclusion Criteria:

• body mass index (BMI) ≥18.0 and ≤30.0 kg/m2

Exclusion Criteria:

• Clinically significant allergic reactions
• Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator
• Hepatic dysfunction upper limit of normal laboratory range
• Cardiac history or presence
• History or any concomitant active malignancy
• A known infection with human immunodeficiency virus, hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Inherited bleeding diathesis or coagulopathy with the risk of bleeding
• Hemoptysis, thrombotic or hemorrhagic event
• Cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage
• History and/or sign/symptoms of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
• Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption