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

Primary Purpose

Acute Radiation Syndrome

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

KMRC011 5μg or Placebo

KMRC011 10μg or Placebo

KMRC011 15μg or Placebo

KMRC011 20μg or Placebo

KMRC011 25μg or Placebo

About this trial

This is an interventional treatment trial for Acute Radiation Syndrome

Eligibility Criteria

19 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Arm Label

KMRC011 5μg or Placebo

KMRC011 10μg or Placebo

KMRC011 15μg or Placebo

KMRC011 20μg or Placebo

KMRC011 25μg or Placebo

Arm Description

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

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

Number of subjects with clinically significant physical abnormality after injection

Maximum serum concentration (Cmax) of KMRC011

Time of the maximum serum concentration (Tmax) of KMRC011

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

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

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

Apparent clearance (CL/F) of KMRC011

Apparent volume of distribution (Vd/F) of KMRC011

Terminal half-life (t1/2) of KMRC011

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

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

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

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

Secondary Outcome Measures

Maximum Tolerated Dose (MTD) of KMRC011

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.

Full Information

NCT ID

NCT03585803

First Posted

June 3, 2018

Last Updated

January 27, 2021

Sponsor

Intron Biotechnology, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03585803

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

June 11, 2018 (Actual)

Primary Completion Date

September 11, 2019 (Actual)

Study Completion Date

November 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intron Biotechnology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Radiation Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KMRC011 5μg or Placebo

Arm Type

Other

Arm Description

Cohort 1

Arm Title

KMRC011 10μg or Placebo

Arm Type

Other

Arm Description

Cohort 2

Arm Title

KMRC011 15μg or Placebo

Arm Type

Other

Arm Description

Cohort 3

Arm Title

KMRC011 20μg or Placebo

Arm Type

Other

Arm Description

Cohort 4

Arm Title

KMRC011 25μg or Placebo

Arm Type

Other

Arm Description

Cohort 5

Intervention Type

Drug

Intervention Name(s)

KMRC011 5μg or Placebo

Other Intervention Name(s)

Cohort 1

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

KMRC011 10μg or Placebo

Other Intervention Name(s)

Cohort 2

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

KMRC011 15μg or Placebo

Other Intervention Name(s)

Cohort 3

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

KMRC011 20μg or Placebo

Other Intervention Name(s)

Cohort 4

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

KMRC011 25μg or Placebo

Other Intervention Name(s)

Cohort 5

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Up to 7±1 days after injection

Title

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

Time Frame

Up to 7±1 days after injection

Title

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

Time Frame

Up to 7±1 days after injection

Title

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

Time Frame

Up to 7±1 days after injection

Title

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

Time Frame

Up to 7±1 days after injection

Title

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

Time Frame

Up to 7±1 days after injection

Title

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

Time Frame

Up to 7±1 days after injection

Title

Number of subjects with clinically significant physical abnormality after injection

Time Frame

Up to 7±1 days after injection

Title

Maximum serum concentration (Cmax) of KMRC011

Time Frame