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

Acute Radiation Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585803
• Other study ID #: KMRC011-01
• Status: Completed
• Phase: Phase 1
• Start date: June 11, 2018
• Est. completion date: November 28, 2019

Study information

• Verified date: January 2021
• Source: Intron Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 28, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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 ?-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

Related Conditions & MeSH terms

• Acute Radiation Syndrome
• Radiation Injuries

Intervention

Drug:
• KMRC011 5µg or Placebo
Intramuscular Injection of KMRC011 5µg or Placebo(Normal Saline) 0.1ml
• KMRC011 10µg or Placebo
Intramuscular Injection of KMRC011 10µg or Placebo(Normal Saline) 0.2ml
• KMRC011 15µg or Placebo
Intramuscular Injection of KMRC011 15µg or Placebo(Normal Saline) 0.3ml
• KMRC011 20µg or Placebo
Intramuscular Injection of KMRC011 30µg or Placebo(Normal Saline) 0.4ml
• KMRC011 25µg or Placebo
Intramuscular Injection of KMRC011 45µg or Placebo(Normal Saline) 0.5ml

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Gangnam-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Intron Biotechnology, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects who expressed Anti-Drug (KMRC011) Antibody (ADA)		Up to 28±2 days after injection
Primary	Number of subjects with treatment-emergent adverse event or adverse drug reaction		Up to 7±1 days after injection
Primary	Number of subjects with clinically significant changes in hematology test result after injection		Up to 7±1 days after injection
Primary	Number of subjects with clinically significant changes in blood chemistry test result after injection		Up to 7±1 days after injection
Primary	Number of subjects with clinically significant changes in urinalysis test result after injection		Up to 7±1 days after injection
Primary	Number of subjects with clinically significant changes in blood coagulation test result after injection		Up to 7±1 days after injection
Primary	Number of subjects with clinically significant changes in ECG (Electrocardiogram) after injection		Up to 7±1 days after injection
Primary	Number of subjects with clinically significant changes in vital sign after injection		Up to 7±1 days after injection
Primary	Number of subjects with clinically significant physical abnormality after injection		Up to 7±1 days after injection
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Until the study completion, approximately up to 35 weeks