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 because the information has not been verified recently.
Verified March 2012 by Biotoxtech Co., Ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Biotoxtech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01548391
First received: March 5, 2012
Last updated: March 7, 2012
Last verified: March 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Biotoxtech Co., Ltd
ClinicalTrials.gov Identifier: NCT01548391     History of Changes
Other Study ID Numbers: 2012-0070
Study First Received: March 5, 2012
Last Updated: March 7, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014