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

NCT03056209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-04-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Yungjin Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, MD., MBA · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2018-04-16
Completion
2018-04-16

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03056209 on ClinicalTrials.gov