Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011

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: NCT03585803
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Intron Biotechnology, Inc.

Brief Summary:
This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Acute Radiation Syndrome Drug: KMRC011 5μg or Placebo Drug: KMRC011 10μg or Placebo Drug: KMRC011 20μg or Placebo Drug: KMRC011 30μg or Placebo Drug: KMRC011 45μg or Placebo Drug: KMRC011 60μg or Placebo Drug: KMRC011 75μg or Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Dose Blocked-Randomized, Single-Blind, Placebo-Controlled and Dose-Escalation Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011 After Intramuscular Administration in Healthy Adult Volunteers
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 31, 2019

Arm Intervention/treatment
KMRC011 5μg or Placebo
Cohort 1
Drug: KMRC011 5μg or Placebo
Intramuscular Injection of KMRC011 5μg or Placebo(Normal Saline) 0.1ml
Other Name: Cohort 1

KMRC011 10μg or Placebo
Cohort 2
Drug: KMRC011 10μg or Placebo
Intramuscular Injection of KMRC011 10μg or Placebo(Normal Saline) 0.2ml
Other Name: Cohort 2

KMRC011 20μg or Placebo
Cohort 3
Drug: KMRC011 20μg or Placebo
Intramuscular Injection of KMRC011 20μg or Placebo(Normal Saline) 0.4ml
Other Name: Cohort 3

KMRC011 30μg or Placebo
Cohort 4
Drug: KMRC011 30μg or Placebo
Intramuscular Injection of KMRC011 30μg or Placebo(Normal Saline) 0.6ml
Other Name: Cohort 4

KMRC011 45μg or Placebo
Cohort 5
Drug: KMRC011 45μg or Placebo
Intramuscular Injection of KMRC011 45μg or Placebo(Normal Saline) 0.9ml
Other Name: Cohort 5

KMRC011 60μg or Placebo
Cohort 6
Drug: KMRC011 60μg or Placebo
Intramuscular Injection of KMRC011 60μg or Placebo(Normal Saline) 1.2ml
Other Name: Cohort 6

KMRC011 75μg or Placebo
Cohort 7
Drug: KMRC011 75μg or Placebo
Intramuscular Injection of KMRC011 75μg or Placebo(Normal Saline) 1.5ml
Other Name: Cohort 7




Primary Outcome Measures :
  1. Number of subjects with treatment-emergent adverse event or adverse drug reaction [ Time Frame: Up to 7±1 days after injection ]
  2. Number of subjects with clinically significant changes in hematology test result after injection [ Time Frame: Up to 7±1 days after injection ]
  3. Number of subjects with clinically significant changes in blood chemistry test result after injection [ Time Frame: Up to 7±1 days after injection ]
  4. Number of subjects with clinically significant changes in urinalysis test result after injection [ Time Frame: Up to 7±1 days after injection ]
  5. Number of subjects with clinically significant changes in blood coagulation test result after injection [ Time Frame: Up to 7±1 days after injection ]
  6. Number of subjects with clinically significant changes in ECG (Electrocardiogram) after injection [ Time Frame: Up to 7±1 days after injection ]
  7. Number of subjects with clinically significant changes in vital sign after injection [ Time Frame: Up to 7±1 days after injection ]
  8. Number of subjects with clinically significant physical abnormality after injection [ Time Frame: Up to 7±1 days after injection ]
  9. Maximum serum concentration (Cmax) of KMRC011 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose ]
  10. Time of the maximum serum concentration (Tmax) of KMRC011 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose ]
  11. Area under the serum concentration versus time curve, from time 0 to the last measurable concentration (AUC0-t) of KMRC011 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose ]
  12. Area under the serum concentration versus time curve from time 0 to infinity (AUCinf) of KMRC011 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose ]
  13. Percentage of AUCinf due to extrapolation from time of last measurable concentration to infinity (AUCextra) of KMRC011 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose ]
  14. Apparent clearance (CL/F) of KMRC011 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose ]
  15. Apparent volume of distribution (Vd/F) of KMRC011 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose ]
  16. Terminal half-life (t1/2) of KMRC011 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose ]
  17. Maximum effect over the time span specified (Emax) of G-CSF [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose ]
  18. Maximum effect over the time span specified (Emax) of IL-6 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose ]
  19. Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of G-CSF [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose ]
  20. Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of IL-6 [ Time Frame: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose ]

Secondary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of KMRC011 [ Time Frame: Until the study completion, approximately up to 35 weeks ]
    A dose that is one level lower than the dose which Dose Limiting Toxicity (DLT) incidence is 33% or more is determined as a Maximum Tolerated Dose (MTD). If the Dose Limiting Toxicity (DLT) incidence is lower than 33% at all doses level, we conclude Maximum Tolerated Dose (MTD) cannot be determined.


Other Outcome Measures:
  1. Number of subjects who expressed Anti-Drug (KMRC011) Antibody (ADA) [ Time Frame: Up to 28±2 days after injection ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male whose age is between 19 and 55 years of age
  • A person whose body mass index is between 18.5 and 27 kg/m2 at screening
  • A person who has the ability and willingness to participate in the clinical trial
  • A person who voluntarily agrees with the clinical trial after hearing and fully understanding the detailed explanation of this clinical trial

Exclusion Criteria:

  • A person who has a clinically significant disease or history of liver, kidney, neuropsychiatry, immune system, respiratory system, endocrine system, hematology*oncology system, cardiovascular system, etc.(In the case of liver disease items, it includes subjects who have hepatitis virus)
  • A person who has clinical history of hypersensitivity reactions to the major components or constituents of investigational product or other clinically significant hypersensitivity reactions to drugs or foods, or those with allergic diseases requiring treatment
  • A person with infectious disease or severe trauma within 21 days of the randomization date
  • A person whose serum AST, ALT or γ-GT levels exceed 1.5 times the upper limit of the reference range at screening
  • A person whose QTcF on the electrocardiogram exceeds 430 msec or who has a clinically significant abnormal rhythm at screening
  • A person with a glomerular filtration rate less than 60 mL/min/1.73 m2 calculated from serum creatinine at screening
  • A person with a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 60 mmHg, or greater than 100 mmHg at screening
  • A person with thrombocytopenia or coagulopathy which should not be given intramuscular injection
  • A person whose weekly average drinking amount exceeds 140g of alcohol per week
  • A person whose daily average smoking amount exceeds 10 per day
  • A person who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the investigational product within 14 days of the injection
  • A person who has the history of substance abuse or positive urine screening test
  • A person who have received a investigational product or a bioequivalence study drug within at least 90 days prior to the randomization
  • A person who donated whole blood within 60 days before the randomization, or donated components of blood within 30 days
  • A person who dose not have a medically approved contraceptive during the trial and has a plan to provide sperm
  • A person who has clinically significant abnormalities from clinical laboratory test
  • A person who is deemed ineligible for clinical trials by the investigator

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): NCT03585803


Contacts
Layout table for location contacts
Contact: Sooyoun Jun, PhD +82-31-739-5332 jsy@intron.co.kr

Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center Recruiting
Gangnam-gu, Seoul, Korea, Republic of, 06351
Contact: Jung-Ryul Kim, MD, PhD    +82-2-3410-3686    jungryul.kim@samsung.com   
Contact: Seokuee Kim, MD, PhD    +82-2-3410-0636    seokuee.kim@samsung.com   
Sponsors and Collaborators
Intron Biotechnology, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jung-Ryul Kim, MD, PhD Samsung Medical Center

Layout table for additonal information
Responsible Party: Intron Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT03585803     History of Changes
Other Study ID Numbers: KMRC011-01
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Radiation Injuries
Acute Radiation Syndrome
Wounds and Injuries