A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects
This study is not yet open for participant recruitment.
Verified March 2012 by Biotoxtech Co., Ltd
Sponsor:
Biotoxtech Co., Ltd
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
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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
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 May 16, 2013