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

Biotoxtech

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: HX-1171

Study type: Interventional

Funder types: Industry

Identifiers

NCT01548391

2012-0070

Details and patient eligibility

About

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

Enrollment: 66 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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66 participants in 9 patient groups

HX-1171 20 mg (20mg 1T)

Experimental group

Treatment:

Drug: HX-1171

HX-1171 40 mg (20mg 2T)

Experimental group

Treatment:

Drug: HX-1171

HX-1171 80 mg (20mg 4T)

Experimental group

Treatment:

Drug: HX-1171

HX-1171 160 mg (20mg 8T)

Experimental group

Treatment:

Drug: HX-1171

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

Experimental group

Treatment:

Drug: HX-1171

HX-1171 600 mg (200mg 3T)

Experimental group

Treatment:

Drug: HX-1171

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

Experimental group

Treatment:

Drug: HX-1171

HX-1171 1500 mg (500mg 3T)

Experimental group

Treatment:

Drug: HX-1171

HX-1171 2000 mg (500mg 4T)

Experimental group

Treatment:

Drug: HX-1171