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

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ClinicalTrials.gov Identifier: NCT01548391
Recruitment Status : Unknown
Verified March 2012 by Biotoxtech Co., Ltd.
Recruitment status was:  Not yet recruiting
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Sponsor:
Information provided by (Responsible Party):
Biotoxtech Co., Ltd

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

Condition or disease Intervention/treatment Phase
Healthy Drug: HX-1171 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Study Start Date : March 2012

Arm Intervention/treatment
Experimental: HX-1171 20 mg (20mg 1T) Drug: HX-1171
20mg, 200mg, 500mg
Experimental: HX-1171 40 mg (20mg 2T) Drug: HX-1171
20mg, 200mg, 500mg
Experimental: HX-1171 80 mg (20mg 4T) Drug: HX-1171
20mg, 200mg, 500mg
Experimental: HX-1171 160 mg (20mg 8T) Drug: HX-1171
20mg, 200mg, 500mg
Experimental: HX-1171 300 mg (200mg 1T, 20mg 5T) Drug: HX-1171
20mg, 200mg, 500mg
Experimental: HX-1171 600 mg (200mg 3T) Drug: HX-1171
20mg, 200mg, 500mg
Experimental: HX-1171 1200 mg (500mg 2T, 200mg 1T) Drug: HX-1171
20mg, 200mg, 500mg
Experimental: HX-1171 1500 mg (500mg 3T) Drug: HX-1171
20mg, 200mg, 500mg
Experimental: HX-1171 2000 mg (500mg 4T) Drug: HX-1171
20mg, 200mg, 500mg



Primary Outcome Measures :
  1. Safety (normal results for safety tests) [ Time Frame: 14days ]
    Physical examination, Vital signs



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
Accepts Healthy Volunteers:   Yes
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): NCT01548391


Locations
Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Kyun-Seop Bae, M.D., Ph.D.    82-2-3010-4611    ksbae@amc.seoul.kr   
Sponsors and Collaborators
Biotoxtech Co., Ltd

Additional Information:
Responsible Party: Biotoxtech Co., Ltd
ClinicalTrials.gov Identifier: NCT01548391     History of Changes
Other Study ID Numbers: 2012-0070
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012