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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 26, 2017

Primary Completion Date

April 16, 2018

Study Completion Date

April 16, 2018

Conditions
MELAS SyndromeMitochondrial 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

Trial Locations (1)

110744

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Yungjin Pharm. Co., Ltd.

INDUSTRY

NCT03056209 - Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers | Biotech Hunter | Biotech Hunter