HealthyPhase 1NCT01800305
PK & PD Study of Pegylated rhEPO, and Evaluated Its Safety and Tolerability in Male Healthy Individual
A Phase 1 study testing Pegylated rhEPO and EPIAO® in people with Healthy, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.
Trial summary
The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pegylated rhEPO and EPIAO®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Oct 2014
- 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 18 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 18 and 40 years, age disparity of each group should less than 10 years.
- Body weight ≥ 50kg, and body mass index (BMI) between 18 kg/m2 and 26kg/m2 at screening.
- Hemoglobin between 131g/L and 162g/L, hematocrit between 41% and 49%, and reticulocyte between 0.5% and 2%.
- Transferrin saturation and serum ferritin are in the normal range.
- Physical condition: vital signs, physical examination and laboratory tests ( including routine blood, biochemical tests, coagulation indicators, serum folic acid, vitamin B12, urine test, HBsAg, anti-HCV, anti-HIV, Immunoglobulin (IgA, IgM, IgG), thyroid function (T3, T4, TSH), autoantibodies), chest-X-ray, 12-lead ECG should all in normal range, or without significant clinically abnormal.
Who cannot join
- Presence of organic disease in heart, liver, kidney, brain; or presence of cardiovascular, pulmonary, gastrointestinal, urinary, neurological, endocrine, immunity, genitourinary or other systems disease.
- Subjects with familial genetic disease, mental illness, or physical disability.
- History of drug allergy.
- Orthostatic hypotension, systolic blood pressure <90mmHg.
- Habitual medication, including Chinese herbal medicine.
- Poor inclusion conditions (e.g. infirm).
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- Smoker (smoke everyday or more than 7 cigarettes per week)，alcoholics (more than 40g/day, equivalent to 100ml/day of 50 degree of white spirit).
- Participate in any other drug trials as the subjects within the previous 3 months.
- As blood donated within the previous 3 months, or experienced massive blood loss due to trauma or surgery.
- Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g. poor compliance).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Positive-controlled, Single-dose, Dose-escalation Phase I Trial to Evaluate Safety & Tolerability, and Explore the Pharmacokinetics and Pharmacodynamics Profile of Pegylated rhEPO in Male Healthy Individual
The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration of the drug and the reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the security and tolerability of the test drug in healthy subjects, and provide sufficient information for dose selection in the future phase II and III study.
- Conditions
- Healthy
- Being tested
- Pegylated rhEPO, EPIAO®
- Keywords
- PK & PD study, rhEPO, Pegylated rhEPO, male healthy subject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated rhEPODrug
EPIAO®Drug
| Study group | Role | What they receive |
|---|---|---|
| Pegylated rhEPO | Experimental | Subcutaneous single-dose administration of 0.5mcg/kg, 1.0mcg/kg, 1.6 mcg/kg, 2.4 mcg/kg, 3.2 mcg/kg，3.2mcg/kg, 4.2mcg/kg, 5.5 mcg/kg, 7.2 mcg/kg, 9.3 mcg/kg (in dose-escalation, if the previous dose is confirmed to be safe.started with the second 3.2mcg/kg dose,Every subject takes Niferex 150mg every day, from day 1 to day 20. ) of the test drug (Pegylated rhEPO) Receives: Drug: Pegylated rhEPO |
| EPIAO® | Active comparator | Subcutaneous six-dose administration of 50IU/kg or 150IU/kg, as randomization, of the comparator drug(EPIAO®) at day 1, 3, 5, 8, 10, 12. Receives: Drug: EPIAO® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of rhEPO
- Time frame of day 12 for comparator drug: 0 hour before drug administration and 1, 3, 6, 9, 14, 16 hour after last dose administration.
- For comparator drug, blood collection of 0, 48, 96, 168, 216, and 264 hour should before drug administration.
Measured: 0 hour before drug administration and 1, 3, 6, 9, 12, 14, 16, 24, 36, ,48, 72, 96, 120, 144, 168, 192, 216,240, 264, 288, 300, 312, 360, 408, 480, 648, 984,1320 hour after drug administration
Plasma reticulocyte count
For comparator drug, blood collection of 48, 96, 168, 216, and 264 hour should before drug administration
Measured: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
Plasma hemoglobin concentration
For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration
Measured: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
Plasma hematocrit
For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration
Measured: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionOct 2014
- Study completionOct 2014
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.
- More trials run by Xiamen Amoytop Biotech Co., Ltd.The sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Zhenman, Ph.D, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800305
- Sponsor's protocol ID
- TB1209EPO
- Status last verified
- Jul 2015
- First submitted
- 24 Feb 2013
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Positive-controlled, Single-dose, Dose-escalation Phase I Trial to Evaluate Safety & Tolerability, and Explore the Pharmacokinetics and Pharmacodynamics Profile of Pegylated rhEPO in Male Healthy Individual
- ClinicalTrials.gov ID
- NCT01800305
- Acronym / sponsor ID
- TB1209EPO
- Conditions
- Healthy
- Keywords
- PK & PD study, rhEPO, Pegylated rhEPO, male healthy subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Xiamen Amoytop Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Feb 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.
The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration of the drug and the reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the security and tolerability of the test drug in healthy subjects, and provide sufficient information for dose selection in the future phase II and III study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegylated rhEPO | Experimental | Drug: Pegylated rhEPOSubcutaneous single-dose administration of 0.5mcg/kg, 1.0mcg/kg, 1.6 mcg/kg, 2.4 mcg/kg, 3.2 mcg/kg，3.2mcg/kg, 4.2mcg/kg, 5.5 mcg/kg, 7.2 mcg/kg, 9.3 mcg/kg (in dose-escalation, if the previous dose is confirmed to be safe.started with the second 3.2mcg/kg dose,Every subject takes Niferex 150mg every day, from day 1 to day 20. ) of the test drug (Pegylated rhEPO) |
| EPIAO® | Active comparator | Drug: EPIAO®Subcutaneous six-dose administration of 50IU/kg or 150IU/kg, as randomization, of the comparator drug(EPIAO®) at day 1, 3, 5, 8, 10, 12. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Agree to all the purposes of the study by signing and dating the informed consent.
- Male, aged between 18 and 40 years, age disparity of each group should less than 10 years.
- Body weight ≥ 50kg, and body mass index (BMI) between 18 kg/m2 and 26kg/m2 at screening.
- Hemoglobin between 131g/L and 162g/L, hematocrit between 41% and 49%, and reticulocyte between 0.5% and 2%.
- Transferrin saturation and serum ferritin are in the normal range.
Key exclusion criteria (10 listed)
- Presence of organic disease in heart, liver, kidney, brain; or presence of cardiovascular, pulmonary, gastrointestinal, urinary, neurological, endocrine, immunity, genitourinary or other systems disease.
- Subjects with familial genetic disease, mental illness, or physical disability.
- History of drug allergy.
- Orthostatic hypotension, systolic blood pressure <90mmHg.
- Habitual medication, including Chinese herbal medicine.
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 |
|---|---|---|
| Pegylated rhEPO | Drug | Pegylated rhEPO |
| EPIAO® | Drug | EPIAO® |
Primary outcome
Serum concentration of rhEPO
Time frame: 0 hour before drug administration and 1, 3, 6, 9, 12, 14, 16, 24, 36, ,48, 72, 96, 120, 144, 168, 192, 216,240, 264, 288, 300, 312, 360, 408, 480, 648, 984,1320 hour after drug administration
* Time frame of day 12 for comparator drug: 0 hour before drug administration and 1, 3, 6, 9, 14, 16 hour after last dose administration. * For comparator drug, blood collection of 0, 48, 96, 168, 216, and 264 hour should before drug administration.
Plasma reticulocyte count
Time frame: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
For comparator drug, blood collection of 48, 96, 168, 216, and 264 hour should before drug administration
Plasma hemoglobin concentration
Time frame: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration
Plasma hematocrit
Time frame: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
For comparator drug, blood collection of 48, 96, 168,216, and 264 hour should before drug administration
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 31 Aug 2015.
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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.
Wei Zhenman, Ph.D principal investigator
Beijing 302 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 Pegylated rhEPO and EPIAO® in people with Healthy, run by Xiamen Amoytop Biotech Co., Ltd. at 1 site in China.
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 6 inclusion and 10 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 31 Aug 2015. 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 China. 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?
Serum concentration of rhEPO (time frame: 0 hour before drug administration and 1, 3, 6, 9, 12, 14, 16, 24, 36, ,48, 72, 96, 120, 144, 168, 192, 216,240, 264, 288, 300, 312, 360, 408, 480, 648, 984,1320 hour after drug administration). The study lists 4 primary outcomes in all. 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 31 Aug 2015.