HealthyPhase 1NCT01548391
A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects
A Phase 1 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 evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HX-1171
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to not given
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- 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.
South Korea1 site
Asan Medical Center
Seoul
Kyun-Seop Bae, M.D., Ph.D., 82-2-3010-4611, ksbae@amc.seoul.kr
About this study
This study is designed to evaluate the safety, tolerability, 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
20mg, 200mg, 500mg
| Study group | Role | What they receive |
|---|---|---|
| HX-1171 20 mg (20mg 1T) | Experimental | Not described Receives: Drug: HX-1171 |
| HX-1171 40 mg (20mg 2T) | Experimental | Not described Receives: Drug: HX-1171 |
| HX-1171 80 mg (20mg 4T) | Experimental | Not described Receives: Drug: HX-1171 |
| HX-1171 160 mg (20mg 8T) | Experimental | Not described Receives: Drug: HX-1171 |
| HX-1171 300 mg (200mg 1T, 20mg 5T) | Experimental | Not described Receives: Drug: HX-1171 |
| HX-1171 600 mg (200mg 3T) | Experimental | Not described Receives: Drug: HX-1171 |
| HX-1171 1200 mg (500mg 2T, 200mg 1T) | Experimental | Not described Receives: Drug: HX-1171 |
| HX-1171 1500 mg (500mg 3T) | Experimental | Not described Receives: Drug: HX-1171 |
| HX-1171 2000 mg (500mg 4T) | Experimental | Not described Receives: Drug: HX-1171 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (normal results for safety tests)
Physical examination, Vital signs
Measured: 14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotoxtech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548391
- Sponsor's protocol ID
- 2012-0070
- Status last verified
- Mar 2012
- First submitted
- 5 Mar 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01548391
- Acronym / sponsor ID
- 2012-0070
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Biotoxtech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- First posted
- 8 Mar 2012 (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 evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| HX-1171 20 mg (20mg 1T) | Experimental | Drug: HX-1171 |
| HX-1171 40 mg (20mg 2T) | Experimental | Drug: HX-1171 |
| HX-1171 80 mg (20mg 4T) | Experimental | Drug: HX-1171 |
| HX-1171 160 mg (20mg 8T) | Experimental | Drug: HX-1171 |
| HX-1171 300 mg (200mg 1T, 20mg 5T) | Experimental | Drug: HX-1171 |
| HX-1171 600 mg (200mg 3T) | Experimental | Drug: HX-1171 |
| HX-1171 1200 mg (500mg 2T, 200mg 1T) | Experimental | Drug: HX-1171 |
| HX-1171 1500 mg (500mg 3T) | Experimental | Drug: HX-1171 |
| HX-1171 2000 mg (500mg 4T) | Experimental | Drug: HX-1171 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- 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-117120mg, 200mg, 500mg | Drug | HX-1171 1200 mg (500mg 2T, 200mg 1T), HX-1171 1500 mg (500mg 3T), HX-1171 160 mg (20mg 8T), HX-1171 20 mg (20mg 1T), HX-1171 2000 mg (500mg 4T), HX-1171 300 mg (200mg 1T, 20mg 5T), HX-1171 40 mg (20mg 2T), HX-1171 600 mg (200mg 3T), HX-1171 80 mg (20mg 4T) |
Primary outcome
Safety (normal results for safety tests)
Time frame: 14days
Physical examination, Vital signs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Clinical Research Center, 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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 8 Mar 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (normal results for safety tests) (time frame: 14days). It is what the study was designed to measure, not a finding.
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 8 Mar 2012.