A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects

Phase 1

• Conditions: Healthy
• Interventions: Drug: HX-1171

• Registration Number: NCT01548391
• Lead Sponsor: Biotoxtech Co., Ltd

Brief Summary

This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-07
• Last Update Submitted: 2012-03-07
• Study First Posted: 2012-03-08
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• Adult males aged 20 to 40 years at screening.
• Be able to comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria

• History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or gastrointestinal disorders.
• History of known hypersensitivity to drugs including HX-1171.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HX-1171 160 mg (20mg 8T)	HX-1171	-
HX-1171 80 mg (20mg 4T)	HX-1171	-
HX-1171 1500 mg (500mg 3T)	HX-1171	-
HX-1171 40 mg (20mg 2T)	HX-1171	-
HX-1171 20 mg (20mg 1T)	HX-1171	-
HX-1171 300 mg (200mg 1T, 20mg 5T)	HX-1171	-
HX-1171 600 mg (200mg 3T)	HX-1171	-
HX-1171 1200 mg (500mg 2T, 200mg 1T)	HX-1171	-
HX-1171 2000 mg (500mg 4T)	HX-1171	-

Primary Outcome Measures

Name	Time	Method
Safety (normal results for safety tests)	14days	Physical examination, Vital signs

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of