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Completed

NCT Number: NCT03585803

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

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

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Key information

Conditions

Acute Radiation Syndrome Radiation Injuries Wounds and Injuries

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Gangnam-gu, Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KMRC011 5μg or Placebo

Drug

Intramuscular Injection of KMRC011 5μg or Placebo(Normal Saline) 0.1ml

Other names: Cohort 1

KMRC011 10μg or Placebo

Drug

Intramuscular Injection of KMRC011 10μg or Placebo(Normal Saline) 0.2ml

Other names: Cohort 2

KMRC011 15μg or Placebo

Drug

Intramuscular Injection of KMRC011 15μg or Placebo(Normal Saline) 0.3ml

Other names: Cohort 3

KMRC011 20μg or Placebo

Drug

Intramuscular Injection of KMRC011 30μg or Placebo(Normal Saline) 0.4ml

Other names: Cohort 4

KMRC011 25μg or Placebo

Drug

Intramuscular Injection of KMRC011 45μg or Placebo(Normal Saline) 0.5ml

Other names: Cohort 5

Primary outcomes

  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 outcomes

  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 outcomes

  1. Number of subjects who expressed Anti-Drug (KMRC011) Antibody (ADA)

    Time frame: Up to 28±2 days after injection

Sponsors and collaborators

Lead sponsor

Intron Biotechnology, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 13, 2018
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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