HealthyPhase 1NCT00846274
Phase1 Syudy to Evaluate the Safety and PK/PD of Human Antithrombin III
A Phase 1 study testing SK Antithrombin III in people with Healthy, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed Read more about this study
- Who is it for?
- Ages 19 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SK Antithrombin III
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2008to Dec 2008
- 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 19 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 19 to 40
- Body weight: More than 50kg
- Healthy male subject
Who cannot join
- Hb<14g/dL, Hct<42%
- ATIII hypersensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Dose, Open Label, Randomized Comparative Clinical Trial to Evaluate the Tolerability, Safety and PK/PD of Human ATIII Products, "SKATIII Injection" and"ATIII Injection" in Healthy Male Subjects
To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed
- Conditions
- Healthy
- Being tested
- SK Antithrombin III
- Keywords
- Healthy Male subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK Antithrombin IIIBiological
| Study group | Role | What they receive |
|---|---|---|
| Antithrombin III | Active comparator | Not described Receives: Biological: SK Antithrombin III |
| SK Antithrombin III | Experimental | Not described Receives: Biological: SK Antithrombin III |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATIII activity
Measured: within 20min after injection ATIII
Secondary outcomes (1)
ATIII antigen
Measured: within 20min after injection ATIII
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korea University Anam Hospital
- Investigators
- Ji Young Park, MD,PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846274
- Sponsor's protocol ID
- SKATIII_I_2007
- Status last verified
- Feb 2009
- First submitted
- 16 Feb 2009
- Last updated
- 18 Feb 2009
- Results posted
- No
Publications
Kim KA, Lim YY, Kim SH, Park JY. Bioequivalence of two intravenous formulations of antithrombin III: a two-way crossover study in healthy Korean subjects. Clin Ther. 2013 Nov;35(11):1752-61. doi: 10.1016/j.clinthera.2013.08.018. Epub 2013 Oct 1.
PubMed 24094463
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose, Open Label, Randomized Comparative Clinical Trial to Evaluate the Tolerability, Safety and PK/PD of Human ATIII Products, "SKATIII Injection" and"ATIII Injection" in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00846274
- Acronym / sponsor ID
- SKATIII_I_2007
- Conditions
- Healthy
- Keywords
- Healthy Male subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Korea University Anam Hospital
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Feb 2009 (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.
To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antithrombin III | Active comparator | Biological: SK Antithrombin III |
| SK Antithrombin III | Experimental | Biological: SK Antithrombin III |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ages 19 to 40
- Body weight: More than 50kg
- Healthy male subject
Key exclusion criteria (2 listed)
- Hb<14g/dL, Hct<42%
- ATIII hypersensitivity
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 |
|---|---|---|
| SK Antithrombin III | Biological | Antithrombin III, SK Antithrombin III |
Primary outcome
ATIII activity
Time frame: within 20min after injection ATIII
1 secondary outcome
ATIII antigen
Time frame: within 20min after injection ATIII
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
- Derived from this study: PubMed 24094463Kim KA, Lim YY, Kim SH, Park JY. Bioequivalence of two intravenous formulations of antithrombin III: a two-way crossover study in healthy Korean subjects. Clin Ther. 2013 Nov;35(11):1752-61. doi: 10.1016/j.clinthera.2013.08.018. Epub 2013 Oct 1.
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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.
Ji Young Park, MD,PhD principal investigator
Korea University Anam Hospital
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 SK Antithrombin III in people with Healthy, run by SK Chemicals 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 3 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: finished, as of the sponsor's last update on 18 Feb 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
ATIII activity (time frame: within 20min after injection ATIII). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00846274, which also lists 1 linked publication.
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 18 Feb 2009.