NCT03918967
Completed
Phase 1
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)
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- CT-G11
- Conditions
- Healthy
- Sponsor
- Celltrion
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
CT-G11
CT-G11 Experimental Drug
Intervention: CT-G11
CT-G20
CT-G20 Experimental Drug
Intervention: CT-G20
CT-G11 Placebo
Intervention: CT-G11 Placebo
CT-G20 Placebo
Intervention: CT-G20 Placebo
Outcomes
Primary Outcomes
Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)
Time Frame: Up to 48 hours after administration
Incidence of Adverse events including serious Adverse events (Part I, Part II)
Time Frame: 46 days
Secondary Outcomes
- PD parameters as assessed by : Left ventricular ejection fraction (LVEF)(17 Days)
- Safety parameters as assessed by: blood pressure of Vital signs(17 Days)
- PK parameters as assessed by : Maximum observed concentration (Cmax)(13 Days)
- PK parameters as assessed by : Terminal half-life time (t1/2)(13 Days)
- Safety parameters as assessed by: clinical chemistry(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)
- Safety parameters as assessed by: pulse rate of Vital signs(17 Days)
- PK parameters as assessed by : Time to Cmax (tmax)(13 Days)
- Safety parameters as assessed by: QT interval of ECG(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)
Study Sites (1)
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