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出境医 / 临床实验 / Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CT-G11 Drug: CT-G20 Drug: CT-G11 Placebo Drug: CT-G20 Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 8, 2019
Actual Primary Completion Date : June 6, 2020
Actual Study Completion Date : June 6, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: CT-G11
CT-G11 Experimental Drug
 Drug: CT-G11
oral tablet of CT-G11 Experimental Drug
Experimental: CT-G20
CT-G20 Experimental Drug
 Drug: CT-G20
oral tablet of CT-G20 Experimental Drug
Placebo Comparator: CT-G11 Placebo Drug: CT-G11 Placebo
oral tablet of Placebo
Placebo Comparator: CT-G20 Placebo Drug: CT-G20 Placebo
oral tablet of Placebo
Outcome Measures
Primary Outcome Measures :
  1. Incidence of Adverse events including serious Adverse events (Part I, Part II) [ Time Frame: 46 days ]
  2. 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 ]

Secondary Outcome Measures :
  1. Safety parameters as assessed by: QT interval of ECG [ Time Frame: 17 Days ]
  2. Safety parameters as assessed by: QTcF of ECG [ Time Frame: 17 Days ]
  3. Safety parameters as assessed by: blood pressure of Vital signs [ Time Frame: 17 Days ]
  4. Safety parameters as assessed by: pulse rate of Vital signs [ Time Frame: 17 Days ]
  5. Safety parameters as assessed by: body temperature of Vital signs [ Time Frame: 17 Days ]
  6. Safety parameters as assessed by: hematology of Clinical laboratory tests [ Time Frame: 17 Days ]
  7. Safety parameters as assessed by: clinical chemistry [ Time Frame: 17 Days ]
  8. PK parameters as assessed by : Area under the concentration-time curve (AUC) [ Time Frame: 13 Days ]
  9. PK parameters as assessed by : Maximum observed concentration (Cmax) [ Time Frame: 13 Days ]
  10. PK parameters as assessed by : Time to Cmax (tmax) [ Time Frame: 13 Days ]
  11. PK parameters as assessed by : Terminal half-life time (t1/2) [ Time Frame: 13 Days ]
  12. PD parameters as assessed by : Left ventricular ejection fraction (LVEF) [ Time Frame: 17 Days ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  • Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption
Contacts and Locations

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Celltrion
Investigators
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Principal Investigator: In-Jin Jang Seoul National University Hospital
Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE April 8, 2019
Actual Primary Completion Date June 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2020)
  • Incidence of Adverse events including serious Adverse events (Part I, Part II) [ Time Frame: 46 days ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019) 		Incidence of Adverse events including serious Adverse events [ Time Frame: 46 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Safety parameters as assessed by: QT interval of ECG [ Time Frame: 17 Days ]
  • Safety parameters as assessed by: QTcF of ECG [ Time Frame: 17 Days ]
  • Safety parameters as assessed by: blood pressure of Vital signs [ Time Frame: 17 Days ]
  • Safety parameters as assessed by: pulse rate of Vital signs [ Time Frame: 17 Days ]
  • Safety parameters as assessed by: body temperature of Vital signs [ Time Frame: 17 Days ]
  • Safety parameters as assessed by: hematology of Clinical laboratory tests [ Time Frame: 17 Days ]
  • Safety parameters as assessed by: clinical chemistry [ Time Frame: 17 Days ]
  • PK parameters as assessed by : Area under the concentration-time curve (AUC) [ Time Frame: 13 Days ]
  • PK parameters as assessed by : Maximum observed concentration (Cmax) [ Time Frame: 13 Days ]
  • PK parameters as assessed by : Time to Cmax (tmax) [ Time Frame: 13 Days ]
  • PK parameters as assessed by : Terminal half-life time (t1/2) [ Time Frame: 13 Days ]
  • PD parameters as assessed by : Left ventricular ejection fraction (LVEF) [ Time Frame: 17 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CT-G11
    oral tablet of CT-G11 Experimental Drug
  • Drug: CT-G20
    oral tablet of CT-G20 Experimental Drug
  • Drug: CT-G11 Placebo
    oral tablet of Placebo
  • Drug: CT-G20 Placebo
    oral tablet of Placebo
Study Arms  ICMJE
  • Experimental: CT-G11
    CT-G11 Experimental Drug
    Intervention: Drug: CT-G11
  • Experimental: CT-G20
    CT-G20 Experimental Drug
    Intervention: Drug: CT-G20
  • Placebo Comparator: CT-G11 Placebo
    Intervention: Drug: CT-G11 Placebo
  • Placebo Comparator: CT-G20 Placebo
    Intervention: Drug: CT-G20 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2020) 		72
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2019) 		48
Actual Study Completion Date  ICMJE June 6, 2020
Actual Primary Completion Date June 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918967
Other Study ID Numbers  ICMJE CT-G20 1.1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celltrion
Study Sponsor  ICMJE Celltrion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: In-Jin Jang Seoul National University Hospital
PRS Account Celltrion
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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