A Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011
NCT ID: NCT03585803
Last Updated: 2021-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2018-06-11
2019-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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KMRC011 5μg or Placebo
Cohort 1
KMRC011 5μg or Placebo
Intramuscular Injection of KMRC011 5μg or Placebo(Normal Saline) 0.1ml
KMRC011 10μg or Placebo
Cohort 2
KMRC011 10μg or Placebo
Intramuscular Injection of KMRC011 10μg or Placebo(Normal Saline) 0.2ml
KMRC011 15μg or Placebo
Cohort 3
KMRC011 15μg or Placebo
Intramuscular Injection of KMRC011 15μg or Placebo(Normal Saline) 0.3ml
KMRC011 20μg or Placebo
Cohort 4
KMRC011 20μg or Placebo
Intramuscular Injection of KMRC011 30μg or Placebo(Normal Saline) 0.4ml
KMRC011 25μg or Placebo
Cohort 5
KMRC011 25μg or Placebo
Intramuscular Injection of KMRC011 45μg or Placebo(Normal Saline) 0.5ml
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
55 Years
MALE
Yes
Sponsors
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Intron Biotechnology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jung-Ryul Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Gangnam-gu, Seoul, South Korea
Countries
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Other Identifiers
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KMRC011-01
Identifier Type: -
Identifier Source: org_study_id
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