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NCT01548391 Clinical Trial

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

Healthy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01548391
Other study ID # 2012-0070
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received March 5, 2012
Last updated March 7, 2012
Start date March 2012

Study information
Verified date March 2012
Source Biotoxtech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 66
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• HX-1171
20mg, 200mg, 500mg

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Biotoxtech Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (normal results for safety tests) Physical examination, Vital signs 14days
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