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Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056209
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Yungjin Pharm. Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 5, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date April 27, 2018
Actual Study Start Date  ICMJE June 26, 2017
Actual Primary Completion Date April 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
Number of reported adverse events [ Time Frame: from day 1 to day 15 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03056209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Maximum plasma concentration (Cmax) of KL1333 [ Time Frame: from day 1 to day 15 ]
  • Area Under the Curve (AUC) of KL1333 [ Time Frame: from day 1 to day 15 ]
  • Half-life (T1/2) of KL1333 [ Time Frame: from day 1 to day 15 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers
Official Title  ICMJE A Dose Block-randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation, Phase I Clinical Study
Brief Summary The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • MELAS Syndrome
  • Mitochondrial Respiratory Chain Deficiencies
Intervention  ICMJE
  • Drug: KL1333 25 mg
    oral administration, single dose, 25 mg 1 tab
  • Drug: KL1333 50 mg
    oral administration, single dose, 25 mg 2 tabs
  • Drug: KL1333 100 mg
    oral administration, single dose, 100 mg 1 tab
  • Drug: KL1333 200 mg
    oral administration, single dose, 100 mg 2 tabs
  • Drug: KL1333 400 mg
    oral administration, single dose, 100 mg 4 tabs
  • Drug: KL1333 600 mg
    oral administration, single dose, 100 mg 6 tabs
  • Drug: KL1333 800 mg
    oral administration, single dose, 100 mg 8 tabs
  • Drug: Placebo
    oral administration, placebo
Study Arms  ICMJE
  • Experimental: KL1333 25mg
    Group 1
    Interventions:
    • Drug: KL1333 25 mg
    • Drug: Placebo
  • Experimental: KL1333 50mg
    Group 2
    Interventions:
    • Drug: KL1333 50 mg
    • Drug: Placebo
  • Experimental: KL1333 100mg
    Group 3
    Interventions:
    • Drug: KL1333 100 mg
    • Drug: Placebo
  • Experimental: KL1333 200mg
    Group 4
    Interventions:
    • Drug: KL1333 200 mg
    • Drug: Placebo
  • Experimental: KL1333 400mg
    Group 5
    Interventions:
    • Drug: KL1333 400 mg
    • Drug: Placebo
  • Experimental: KL1333 600mg
    Group 6
    Interventions:
    • Drug: KL1333 600 mg
    • Drug: Placebo
  • Experimental: KL1333 800mg
    Group 7
    Interventions:
    • Drug: KL1333 800 mg
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
10
Actual Study Completion Date  ICMJE April 16, 2018
Actual Primary Completion Date April 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 19 - 45 years of age at the time of screening
  • Subjects weighing ≥55 and ≤90 kg with BMI between 18 and 27 kg/m2
  • Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study

Exclusion Criteria:

  • History of clinically significant hepatic, renal, neurologic, immunologic, respiratory, endocrine disease or hematologic•oncologic disease, cardiovascular, psychiatric disease
  • History of disease or surgery of the gastrointestinal tract that could interfere with kinetics of the study drug. Simple hernia repair or appendectomy are excepted.
  • History of clinically significant or relevant allergy/hypersensitivity
  • Blood AST (SGOT), ALT (SGPT) >1.5 of upper limit
  • eGFR value of ≤90mL/min/1.73m2
  • Systolic blood pressure of <100 mmHg or >160 mmHg
  • Diastolic blood pressure of <60 mmHg or >100 mmHg
  • Any abnormalities in 12-lead ECG at screening visit
  • Subjects who showed positive result in drug abuse tests, or who has history of drug abuse within 60 days prior to the time of screening
  • Subjects who took prescribed medications or oriental medicine within 14 days or over-the-counter (OTC) medications or vitamins within 7 days prior to the dose of the study drug (however, the subject can be included if other criteria are met according to the discretion of the investigator)
  • Subjects who were administered any investigational products within 3 months from the first dose of the study drug
  • Subjects who have donated whole blood (60 days) or partial blood (30 days), or received blood transfusion
  • Subjects who have had alcohol consistently (>21units/week, 1unit=10 g of pure alcohol) or who is not able to stop drinking alcohol throughout the study period
  • Subjects who have smoked until 90 days prior to the study initiation or who are not able to stop smoking throughout the study period
  • Subjects who are not able to stop taking grapefruit/caffeine from 3 days prior to the first dose of the study drug throughout the study period
  • Subjects who plan for pregnancy during the study period or who are not able to use established contraceptive method
  • Subject who judged not eligible for study participation by investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056209
Other Study ID Numbers  ICMJE KL1333_101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yungjin Pharm. Co., Ltd.
Study Sponsor  ICMJE Yungjin Pharm. Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kyung-Sang Yu, MD., MBA Seoul National University Hospital
PRS Account Yungjin Pharm. Co., Ltd.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP