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

NCT ID: NCT03056209

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-26
• Study Completion Date: 2018-04-16

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.

Conditions

MELAS Syndrome; Mitochondrial Respiratory Chain Deficiencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

KL1333 25mg

Group 1

Group Type: EXPERIMENTAL

KL1333 25 mg

Intervention Type: DRUG

oral administration, single dose, 25 mg 1 tab

Placebo

Intervention Type: DRUG

oral administration, placebo

KL1333 50mg

Group 2

Group Type: EXPERIMENTAL

KL1333 50 mg

Intervention Type: DRUG

oral administration, single dose, 25 mg 2 tabs

Placebo

Intervention Type: DRUG

oral administration, placebo

KL1333 100mg

Group 3

Group Type: EXPERIMENTAL

KL1333 100 mg

Intervention Type: DRUG

oral administration, single dose, 100 mg 1 tab

Placebo

Intervention Type: DRUG

oral administration, placebo

KL1333 200mg

Group 4

Group Type: EXPERIMENTAL

KL1333 200 mg

Intervention Type: DRUG

oral administration, single dose, 100 mg 2 tabs

Placebo

Intervention Type: DRUG

oral administration, placebo

KL1333 400mg

Group 5

Group Type: EXPERIMENTAL

KL1333 400 mg

Intervention Type: DRUG

oral administration, single dose, 100 mg 4 tabs

Placebo

Intervention Type: DRUG

oral administration, placebo

KL1333 600mg

Group 6

Group Type: EXPERIMENTAL

KL1333 600 mg

Intervention Type: DRUG

oral administration, single dose, 100 mg 6 tabs

Placebo

Intervention Type: DRUG

oral administration, placebo

KL1333 800mg

Group 7

Group Type: EXPERIMENTAL

KL1333 800 mg

Intervention Type: DRUG

oral administration, single dose, 100 mg 8 tabs

Placebo

Intervention Type: DRUG

oral administration, placebo

Interventions

KL1333 25 mg

oral administration, single dose, 25 mg 1 tab

Intervention Type: DRUG

KL1333 50 mg

oral administration, single dose, 25 mg 2 tabs

Intervention Type: DRUG

KL1333 100 mg

oral administration, single dose, 100 mg 1 tab

Intervention Type: DRUG

KL1333 200 mg

oral administration, single dose, 100 mg 2 tabs

Intervention Type: DRUG

KL1333 400 mg

oral administration, single dose, 100 mg 4 tabs

Intervention Type: DRUG

KL1333 600 mg

oral administration, single dose, 100 mg 6 tabs

Intervention Type: DRUG

KL1333 800 mg

oral administration, single dose, 100 mg 8 tabs

Intervention Type: DRUG

Placebo

oral administration, placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yungjin Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-Sang Yu, MD., MBA

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Countries

South Korea

Other Identifiers

KL1333_101

Identifier Type: -

Identifier Source: org_study_id