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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: CT-G11
* Drug: CT-G20
* Drug: CT-G11 Placebo
* Drug: CT-G20 Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-G11<br>CT-G11 Experimental Drug | Drug: CT-G11<br>* oral tablet of CT-G11 Experimental Drug<br>|
| Experimental: CT-G20<br>CT-G20 Experimental Drug | Drug: CT-G20<br>* oral tablet of CT-G20 Experimental Drug<br>|
| Placebo Comparator: CT-G11 Placebo<br> | Drug: CT-G11 Placebo<br>* oral tablet of Placebo<br>|
| Placebo Comparator: CT-G20 Placebo<br> | Drug: CT-G20 Placebo<br>* oral tablet of Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse events including serious Adverse events (Part I, Part II) |  | 46 days | 
| Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III) |  | Up to 48 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters as assessed by: QT interval of ECG |  | 17 Days | 
| Safety parameters as assessed by: QTcF of ECG |  | 17 Days | 
| Safety parameters as assessed by: blood pressure of Vital signs |  | 17 Days | 
| Safety parameters as assessed by: pulse rate of Vital signs |  | 17 Days | 
| Safety parameters as assessed by: body temperature of Vital signs |  | 17 Days | 
| Safety parameters as assessed by: hematology of Clinical laboratory tests |  | 17 Days | 
| Safety parameters as assessed by: clinical chemistry |  | 17 Days | 
| PK parameters as assessed by : Area under the concentration-time curve (AUC) |  | 13 Days | 
| PK parameters as assessed by : Maximum observed concentration (Cmax) |  | 13 Days | 
| PK parameters as assessed by : Time to Cmax (tmax) |  | 13 Days | 
| PK parameters as assessed by : Terminal half-life time (t1/2) |  | 13 Days | 
| PD parameters as assessed by : Left ventricular ejection fraction (LVEF) |  | 17 Days |