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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01889745
Expanded Access Status : Temporarily not available
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
Biotoxtech Co., Ltd

Brief Summary:
This study is designed to multiple dose and dose escalation study

Condition or disease Intervention/treatment
Healthy Drug: HX-1171

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

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Study Type : Expanded Access
Official Title: A Phase I Clinical Study, Randomized, Single-blind,Placebo-controlled, Multiple Doses, Dose Escalation Study fo the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: HX-1171
    Anti-oxidatant, Anti-inflamation
    Other Names:
    • 1-O-hexyl-2,3,5-trimethylhydroquinone
    • HX-1171 500mg

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889745


Locations
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Korea, Republic of
Asan Medical Center
Special City of Seoul, Korea, Republic of
Sponsors and Collaborators
Biotoxtech Co., Ltd
Investigators
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Principal Investigator: Kyun-Seop Bae, M.D., Ph.D Asan Medical Center
Additional Information:
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Responsible Party: Biotoxtech Co., Ltd
ClinicalTrials.gov Identifier: NCT01889745    
Other Study ID Numbers: 2013_0361
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013