Healthy
Conditions
Brief summary
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.
Interventions
DRUGCT-G11
oral tablet of CT-G11 Experimental Drug
DRUGCT-G20
oral tablet of CT-G20 Experimental Drug
DRUGCT-G11 Placebo
oral tablet of Placebo
DRUGCT-G20 Placebo
oral tablet of Placebo
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Safety parameters as assessed by: QT interval of ECG | 17 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 |
| PK parameters as assessed by : Area under the concentration-time curve (AUC) | 13 Days |
| Safety parameters as assessed by: QTcF of ECG | 17 Days |
Countries
South Korea
Outcome results
None listed