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

NCT ID: NCT01548391

Last Updated: 2012-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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HX-1171 20 mg (20mg 1T)

Group Type EXPERIMENTAL

HX-1171

Intervention Type DRUG

20mg, 200mg, 500mg

HX-1171 40 mg (20mg 2T)

Group Type EXPERIMENTAL

HX-1171

Intervention Type DRUG

20mg, 200mg, 500mg

HX-1171 80 mg (20mg 4T)

Group Type EXPERIMENTAL

HX-1171

Intervention Type DRUG

20mg, 200mg, 500mg

HX-1171 160 mg (20mg 8T)

Group Type EXPERIMENTAL

HX-1171

Intervention Type DRUG

20mg, 200mg, 500mg

HX-1171 300 mg (200mg 1T, 20mg 5T)

Group Type EXPERIMENTAL

HX-1171

Intervention Type DRUG

20mg, 200mg, 500mg

HX-1171 600 mg (200mg 3T)

Group Type EXPERIMENTAL

HX-1171

Intervention Type DRUG

20mg, 200mg, 500mg

HX-1171 1200 mg (500mg 2T, 200mg 1T)

Group Type EXPERIMENTAL

HX-1171

Intervention Type DRUG

20mg, 200mg, 500mg

HX-1171 1500 mg (500mg 3T)

Group Type EXPERIMENTAL

HX-1171

Intervention Type DRUG

20mg, 200mg, 500mg

HX-1171 2000 mg (500mg 4T)

Group Type EXPERIMENTAL

HX-1171

Intervention Type DRUG

20mg, 200mg, 500mg

Interventions

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HX-1171

20mg, 200mg, 500mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biotoxtech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Facility Contacts

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Kyun-Seop Bae, M.D., Ph.D.

Role: primary

82-2-3010-4611

Related Links

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http://crc.amc.seoul.kr

Clinical Research Center, Asan Medical Center

Other Identifiers

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2012-0070

Identifier Type: -

Identifier Source: org_study_id

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