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

This study is not yet open for participant recruitment.
Verified February 2017 by KT&G Life Sciences Corp
Sponsor:
ClinicalTrials.gov Identifier:
NCT03056209
First Posted: February 17, 2017
Last Update Posted: February 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Yungjin Pharm. Co., Ltd.
Information provided by (Responsible Party):
KT&G Life Sciences Corp
  Purpose
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.

Condition Intervention Phase
MELAS Syndrome Mitochondrial Respiratory Chain Deficiencies Drug: KL1333 25 mg Drug: KL1333 50 mg Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation, Phase I Clinical Study

Resource links provided by NLM:


Further study details as provided by KT&G Life Sciences Corp:

Primary Outcome Measures:
  • Number of reported adverse events [ Time Frame: from day 1 to day 15 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Anticipated Study Start Date: March 1, 2017
Estimated Study Completion Date: September 1, 2017
Estimated Primary Completion Date: June 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KL1333 25mg
group1
Drug: KL1333 25 mg
oral administration, single dose, 25mg 1tab
Experimental: KL1333 50mg
group 2
Drug: KL1333 50 mg
oral administration, single dose, 25mg 2tab
Placebo Comparator: Placebo Drug: Placebo
oral administration, single dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056209


Contacts
Contact: EUNJU LEE +82-31-303-8837 ejlee@yungjin.co.kr

Sponsors and Collaborators
KT&G Life Sciences Corp
Yungjin Pharm. Co., Ltd.
  More Information

Responsible Party: KT&G Life Sciences Corp
ClinicalTrials.gov Identifier: NCT03056209     History of Changes
Other Study ID Numbers: KL1333_101
First Submitted: February 5, 2017
First Posted: February 17, 2017
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KT&G Life Sciences Corp:
Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation

Additional relevant MeSH terms:
MELAS Syndrome
Mitochondrial Diseases
Mitochondrial Encephalomyopathies
Mitochondrial Myopathies
Muscular Diseases
Musculoskeletal Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Neuromuscular Diseases
Vascular Diseases
Cardiovascular Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases