HealthyHX-1171NCT01889745
A Phase I Clinical Study of the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.
A study testing HX-1171 in people with Healthy, run by Biotoxtech Co., Ltd at 1 site in South Korea.
Trial summary
This study is designed to multiple dose and dose escalation study Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Healthy
- What is being tested?
- HX-1171
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study, Randomized, Single-blind,Placebo-controlled, Multiple Doses, Dose Escalation Study fo the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.
This study is designed to multiple dose and dose escalation study
Read the 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
- Conditions
- Healthy
- Being tested
- HX-1171
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX-1171Drug
Also called 1-O-hexyl-2,3,5-trimethylhydroquinone, HX-1171 500mg
Anti-oxidatant, Anti-inflamation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Biotoxtech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, M.D., Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889745
- Sponsor's protocol ID
- 2013_0361
- Acronym
- HX-1171
- Status last verified
- Jun 2013
- First submitted
- 20 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study, Randomized, Single-blind,Placebo-controlled, Multiple Doses, Dose Escalation Study fo the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT01889745
- Acronym / sponsor ID
- HX-1171 / 2013_0361
- Conditions
- Healthy
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Biotoxtech Co., LtdIndustry (pharma, biotech, devices)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HX-1171Also: 1-O-hexyl-2,3,5-trimethylhydroquinone, HX-1171 500mgAnti-oxidatant, Anti-inflamation | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- Asan medical centerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyun-Seop Bae, M.D., Ph.D principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HX-1171 in people with Healthy, run by Biotoxtech Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.