HealthyPhase 1NCT02426151
Bioequivalence of a Single Subcutaneous Dose of BEPO and REPO in Healthy Male Subjects
A Phase 1 study testing BEPO-A and REPO-A in people with Healthy, run by LG Life Sciences.
Trial summary
To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects 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?
- BEPO-A and REPO-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Sep 2015
- 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
- Agree to all the purposes of the study by signing and dating the Informed Consent;
- Male, aged between 19 and 40 years, clinically healthy;
- BMI between 19 and 28;
- 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP < 85 mmHg
Who cannot join
- Hemoglobin <13 g / dL
- Ferritin <20 ng/mL or TIBC > 360 ug/ dL
- Vitamin B12 < 200 pg/mL or floate < 4 ng/mL
- %reticulpcyte > 3%
- platelet < 100,000/ul or > 400,000/ul
- GFR < 60mL/min/1.73m2
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- Going to or during treatment of the tumor
- Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation
- Clinical history of autoimmune or hereditary anemia
- A Positive reaction in the nicotine tests
- Principal Investigator of the study criteria.
About this study
Official title: A Randomized, Open Label, Single-dose 2x2 Crossover Study to Compare Pharmacokinetic, Pharmacodynamic Profiles, and Tolerability of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects
To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects
Read the detailed description
To Compare Pharmacokinetic and Pharmacodynamic Profiles of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects
- Conditions
- Healthy
- Being tested
- BEPO-A, REPO-A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEPO-ADrug
BEPO-A (Bioreactor manufacturing process)
REPO-ADrug
REPO-A (Roller bottle manufacturing process)
| Study group | Role | What they receive |
|---|---|---|
| BEPO-A | Experimental | Single subcutaneous injection of BEPO-A 4000 IU (Bioreactor manufacturing process) Receives: Drug: BEPO-A |
| REPO-A | Active comparator | Single subcutaneous injection of REPO-A 4000 IU (Roller bottle manufacturing process) Receives: Drug: REPO-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax and AUClast
Measured: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,
Secondary outcomes (1)
AUCinf, Tmax, t1/2β, CL/F, MRTinf (mean residence time) of Erythropoietin
Measured: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2015
- Study completionSep 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426151
- Sponsor's protocol ID
- LG-EPCL009
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2015
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single-dose 2x2 Crossover Study to Compare Pharmacokinetic, Pharmacodynamic Profiles, and Tolerability of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02426151
- Acronym / sponsor ID
- LG-EPCL009
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Apr 2015 (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 Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects
Detailed description
To Compare Pharmacokinetic and Pharmacodynamic Profiles of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BEPO-A | Experimental | Drug: BEPO-ASingle subcutaneous injection of BEPO-A 4000 IU (Bioreactor manufacturing process) |
| REPO-A | Active comparator | Drug: REPO-ASingle subcutaneous injection of REPO-A 4000 IU (Roller bottle manufacturing process) |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Agree to all the purposes of the study by signing and dating the Informed Consent;
- Male, aged between 19 and 40 years, clinically healthy;
- BMI between 19 and 28;
- 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP < 85 mmHg
Key exclusion criteria (11 listed)
- Hemoglobin <13 g / dL
- Ferritin <20 ng/mL or TIBC > 360 ug/ dL
- Vitamin B12 < 200 pg/mL or floate < 4 ng/mL
- %reticulpcyte > 3%
- platelet < 100,000/ul or > 400,000/ul
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 |
|---|---|---|
| BEPO-ABEPO-A (Bioreactor manufacturing process) | Drug | BEPO-A |
| REPO-AREPO-A (Roller bottle manufacturing process) | Drug | REPO-A |
Primary outcome
Cmax and AUClast
Time frame: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,
1 secondary outcome
AUCinf, Tmax, t1/2β, CL/F, MRTinf (mean residence time) of Erythropoietin
Time frame: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,
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 Mar 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BEPO-A and REPO-A in people with Healthy, run by LG Life Sciences.
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 4 inclusion and 11 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 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Cmax and AUClast (time frame: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,). 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 18 Mar 2016.