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

MELAS Syndrome Clinical Trial

Official title:

A Dose Block-randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation, Phase I Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056209
• Other study ID #: KL1333_101
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2017
• Last updated: April 25, 2018
• Start date: June 26, 2017
• Est. completion date: April 16, 2018

Study information

• Verified date: April 2018
• Source: Yungjin Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 16, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• MELAS Syndrome
• Mitochondrial Diseases
• Mitochondrial Respiratory Chain Deficiencies

Intervention

Drug:
• KL1333 25 mg
oral administration, single dose, 25 mg 1 tab
• KL1333 50 mg
oral administration, single dose, 25 mg 2 tabs
• KL1333 100 mg
oral administration, single dose, 100 mg 1 tab
• KL1333 200 mg
oral administration, single dose, 100 mg 2 tabs
• KL1333 400 mg
oral administration, single dose, 100 mg 4 tabs
• KL1333 600 mg
oral administration, single dose, 100 mg 6 tabs
• KL1333 800 mg
oral administration, single dose, 100 mg 8 tabs
• Placebo
oral administration, placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Yungjin Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of reported adverse events		from day 1 to day 15
Secondary	Maximum plasma concentration (Cmax) of KL1333		from day 1 to day 15
Secondary	Area Under the Curve (AUC) of KL1333		from day 1 to day 15
Secondary	Half-life (T1/2) of KL1333		from day 1 to day 15