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

NCT03585803 | Completed Phase 1

• 1 other identifier: KMRC011-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Radiation Syndrome

Outcome Measures

Primary Outcomes (20)

• Number of subjects with treatment-emergent adverse event or adverse drug reaction

  Up to 7±1 days after injection

• Number of subjects with clinically significant changes in hematology test result after injection

  Up to 7±1 days after injection

• Number of subjects with clinically significant changes in blood chemistry test result after injection

  Up to 7±1 days after injection

• Number of subjects with clinically significant changes in urinalysis test result after injection

  Up to 7±1 days after injection

• Number of subjects with clinically significant changes in blood coagulation test result after injection

  Up to 7±1 days after injection

• Number of subjects with clinically significant changes in ECG (Electrocardiogram) after injection

  Up to 7±1 days after injection

• Number of subjects with clinically significant changes in vital sign after injection

  Up to 7±1 days after injection

• Number of subjects with clinically significant physical abnormality after injection

  Up to 7±1 days after injection

• Maximum serum concentration (Cmax) of KMRC011

  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

• Time of the maximum serum concentration (Tmax) of KMRC011

  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

• Area under the serum concentration versus time curve, from time 0 to the last measurable concentration (AUC0-t) of KMRC011

  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

• Area under the serum concentration versus time curve from time 0 to infinity (AUCinf) of KMRC011

  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

• Percentage of AUCinf due to extrapolation from time of last measurable concentration to infinity (AUCextra) of KMRC011

  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

• Apparent clearance (CL/F) of KMRC011

  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

• Apparent volume of distribution (Vd/F) of KMRC011

  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

• Terminal half-life (t1/2) of KMRC011

  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

• Maximum effect over the time span specified (Emax) of G-CSF

  Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose

• Maximum effect over the time span specified (Emax) of IL-6

  Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose

• Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of G-CSF

  Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose

• Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of IL-6

  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

  Until the study completion, approximately up to 35 weeks

Other Outcomes (1)

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

  Up to 28±2 days after injection

Study Arms (5)

KMRC011 5μg or Placebo

OTHER

Cohort 1

Drug: KMRC011 5μg or Placebo

KMRC011 10μg or Placebo

OTHER

Cohort 2

Drug: KMRC011 10μg or Placebo

KMRC011 15μg or Placebo

OTHER

Cohort 3

Drug: KMRC011 15μg or Placebo

KMRC011 20μg or Placebo

OTHER

Cohort 4

Drug: KMRC011 20μg or Placebo

KMRC011 25μg or Placebo

OTHER

Cohort 5

Drug: KMRC011 25μg or Placebo

Interventions

KMRC011 5μg or Placebo DRUG

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

Also known as: Cohort 1

KMRC011 5μg or Placebo

KMRC011 10μg or Placebo DRUG

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

Also known as: Cohort 2

KMRC011 10μg or Placebo

KMRC011 15μg or Placebo DRUG

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

Also known as: Cohort 3

KMRC011 15μg or Placebo

KMRC011 20μg or Placebo DRUG

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

Also known as: Cohort 4

KMRC011 20μg or Placebo

KMRC011 25μg or Placebo DRUG

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

Also known as: Cohort 5

KMRC011 25μg or Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intron Biotechnology, Inc.: lead

Study Sites (1)

Samsung Medical Center

Gangnam-gu, Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Acute Radiation Syndrome

Interventions

KMRC011; KPNA1 protein, human

Condition Hierarchy (Ancestors)

Radiation Injuries; Wounds and Injuries

Study Officials

• Jung-Ryul Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2018
• First Posted: July 13, 2018
• Study Start: June 11, 2018
• Primary Completion: September 11, 2019
• Study Completion: November 28, 2019
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

KR (1)