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

March 7, 2012 updated by: Biotoxtech Co., Ltd
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (normal results for safety tests)
Time Frame: 14days
Physical examination, Vital signs
14days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotoxtech Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-0070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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