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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
MELAS Syndrome Mitochondrial Respiratory Chain Deficiencies Drug: KL1333 25 mg Drug: KL1333 50 mg Drug: KL1333 100 mg Drug: KL1333 200 mg Drug: KL1333 400 mg Drug: KL1333 600 mg Drug: KL1333 800 mg Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Actual Study Start Date : June 26, 2017
Actual Primary Completion Date : April 16, 2018
Actual Study Completion Date : April 16, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: KL1333 25mg
Group 1
 Drug: KL1333 25 mg
oral administration, single dose, 25 mg 1 tab

Drug: Placebo
oral administration, placebo
Experimental: KL1333 50mg
Group 2
 Drug: KL1333 50 mg
oral administration, single dose, 25 mg 2 tabs

Drug: Placebo
oral administration, placebo
Experimental: KL1333 100mg
Group 3
 Drug: KL1333 100 mg
oral administration, single dose, 100 mg 1 tab

Drug: Placebo
oral administration, placebo
Experimental: KL1333 200mg
Group 4
 Drug: KL1333 200 mg
oral administration, single dose, 100 mg 2 tabs

Drug: Placebo
oral administration, placebo
Experimental: KL1333 400mg
Group 5
 Drug: KL1333 400 mg
oral administration, single dose, 100 mg 4 tabs

Drug: Placebo
oral administration, placebo
Experimental: KL1333 600mg
Group 6
 Drug: KL1333 600 mg
oral administration, single dose, 100 mg 6 tabs

Drug: Placebo
oral administration, placebo
Experimental: KL1333 800mg
Group 7
 Drug: KL1333 800 mg
oral administration, single dose, 100 mg 8 tabs

Drug: Placebo
oral administration, placebo


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

Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of KL1333 [ Time Frame: from day 1 to day 15 ]
  2. Area Under the Curve (AUC) of KL1333 [ Time Frame: from day 1 to day 15 ]
  3. Half-life (T1/2) of KL1333 [ Time Frame: from day 1 to day 15 ]

Eligibility Criteria
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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
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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


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Jongno-gu, Korea, Republic of, 110744
Sponsors and Collaborators
Yungjin Pharm. Co., Ltd.
Investigators
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Study Chair: Kyung-Sang Yu, MD., MBA Seoul National University Hospital
More Information
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Responsible Party: Yungjin Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03056209    
Other Study ID Numbers: KL1333_101
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yungjin Pharm. Co., Ltd.:
Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
Additional relevant MeSH terms:
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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