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To Demonstrate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 in Human Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03918967
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief Summary:
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 in human participants. This is a double-blinded, sequential group, single and multiple ascending (oral) dose study in healthy volunteers aged 19-55 years.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 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
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: CT-G11
CT-G11 Experimental Drug
Drug: CT-G11
Multiple dose, oral tablet of CT-G11 Experimental Drug

Experimental: CT-G20
CT-G20 Experimental Drug
Drug: CT-G20
Single dose, oral tablet of CT-G20 Experimental Drug

Placebo Comparator: CT-G11 Placebo Drug: CT-G11 Placebo
Multiple dose, oral tablet of Placebo

Placebo Comparator: CT-G20 Placebo Drug: CT-G20 Placebo
Single dose, oral tablet of Placebo




Primary Outcome Measures :
  1. Incidence of Adverse events including serious Adverse events [ Time Frame: 46 days ]

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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918967


Contacts
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Contact: Boram Lee +82-2-3403-9659 Boram.lee@celltrion.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: In-Jin Jang         
Sponsors and Collaborators
Celltrion
Investigators
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Principal Investigator: In-Jin Jang Seoul National University Hospital

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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT03918967     History of Changes
Other Study ID Numbers: CT-G20 1.1
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No