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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01548391
Enrollment
66
Registered
2012-03-08
Start date
2012-03-31
Completion date
Unknown
Last updated
2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

20mg, 200mg, 500mg

Sponsors

Biotoxtech Co., Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Safety (normal results for safety tests)14daysPhysical examination, Vital signs

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026