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

iNtRON Biotechnology

Status and phase: Completed; Phase 1

Conditions: Acute Radiation Syndrome

Treatments: Drug: KMRC011 10μg or Placebo; Drug: KMRC011 15μg or Placebo; Drug: KMRC011 5μg or Placebo; Drug: KMRC011 25μg or Placebo; Drug: KMRC011 20μg or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03585803

KMRC011-01

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 5 patient groups

KMRC011 5μg or Placebo

Other group

Description:

Cohort 1

Treatment:

Drug: KMRC011 5μg or Placebo

KMRC011 10μg or Placebo

Other group

Description:

Cohort 2

Treatment:

Drug: KMRC011 10μg or Placebo

KMRC011 15μg or Placebo

Other group

Description:

Cohort 3

Treatment:

Drug: KMRC011 15μg or Placebo

KMRC011 20μg or Placebo

Other group

Description:

Cohort 4

Treatment:

Drug: KMRC011 20μg or Placebo

KMRC011 25μg or Placebo

Other group

Description:

Cohort 5

Treatment:

Drug: KMRC011 25μg or Placebo