A Phase I Clinical Study of the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.
- Conditions
- Healthy
- Registration Number
- NCT01889745
- Lead Sponsor
- Biotoxtech Co., Ltd
- Brief Summary
This study is designed to multiple dose and dose escalation study
- Detailed Description
A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Single Dose Escalation Study of the Safety, Tolerabiluty, and Pharmacokinetics of HX-1171 in Healthy Male Subjects
Recruitment & Eligibility
- Status
- TEMPORARILY_NOT_AVAILABLE
- Sex
- Male
- Target Recruitment
- Not specified
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 & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of HX-1171 in healthy male subjects as studied in NCT01889745?
How does HX-1171 compare to standard-of-care treatments in terms of pharmacokinetics and tolerability?
What biomarkers are associated with the safety and pharmacokinetics of HX-1171 in phase I trials?
What adverse events are reported in phase I studies of HX-1171 and how are they managed?
Are there related compounds or competitor drugs to HX-1171 in development for similar therapeutic applications?
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Special City of Seoul, Korea, Republic of
Asan Medical Center🇰🇷Special City of Seoul, Korea, Republic of