NCT03056209

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Yungjin Pharm. Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-06-26
• Primary completion: 2018-04-16
• Completion: 2018-04-16
• First posted: 2017-02-17
• Last updated: 2018-04-27

Locations

1 site across 1 country: South Korea