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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Biotoxtech Co., Ltd.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548391
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
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.
Information provided by (Responsible Party):
Biotoxtech Co., Ltd
  Purpose
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.

Condition Intervention Phase
Healthy Drug: HX-1171 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care

Further study details as provided by Biotoxtech Co., Ltd:

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


Estimated Enrollment: 66
Study Start Date: March 2012
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Biotoxtech Co., Ltd
ClinicalTrials.gov Identifier: NCT01548391     History of Changes
Other Study ID Numbers: 2012-0070
First Submitted: March 5, 2012
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
Last Verified: March 2012