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

• Conditions: Healthy

• Registration Number: NCT01889745
• Lead Sponsor: Biotoxtech Co., Ltd

Brief Summary

This study is designed to multiple dose and dose escalation study

Detailed Description

A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Single Dose Escalation Study of the Safety, Tolerabiluty, and Pharmacokinetics of HX-1171 in Healthy Male Subjects

Study Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-20
• Last Update Submitted: 2013-06-20
• Study First Posted: 2013-06-28
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: TEMPORARILY_NOT_AVAILABLE
• Sex: Male
• Target Recruitment: Not specified

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: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

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