HealthyPhase 1EPONCT01030315
A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects
A Phase 1 study of Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
Study design: Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose escalation study of intravenously administered HM10760A in healthy adult Caucasian and Japanese subjects. Up to 5 dose level cohorts are planned. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian and Japanese male and/or female volunteers
- Age 18 to 55 years
- Hemoglobin of >12 g/dL and <16 g/dL for male subjects, >10 g/dL and <14 g/dL for female Caucasian subjects
Who cannot join
- Prior exposure to EPO, darbepoetin, other EPO support proteins
- hypersensitivity to EPO, darbepoetin, E.coli derived proteins
- Hemoglobinopathy
- SBP > 140 mmHg or < 90 mmHg or DBP > 95 mmHg
- Chronic, uncontrolled, or symptomatic inflammatory disease
- Malignancy(except non-melanoma skin cancer)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics and Pharmacokinetics of Single Intravenous Doses of HM10760A in Healthy Adult Caucasian and Japanese Subjects
Study design:
- Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose escalation study of intravenously administered HM10760A in healthy adult Caucasian and Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort, subjects will be randomized to receive a single dose of HM10760A or placebo.
Primary Objective:
- To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy adult Caucasian and Japanese subjects.
Read the detailed description
Secondary Objectives:
- To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters
- To assess the immunogenicity of a single IV dose of HM10760A.
- Conditions
- Healthy
- Being tested
- HM10760A or placebo
- Keywords
- Erythropoietin, Long-acting, EPO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM10760A or placeboDrug
Once, 0.04 mcg/kg to 2.0mcg/kg once intravenously
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | The lowest dose level of HM10760A Receives: Drug: HM10760A or placebo |
| Cohort 2 | Experimental | Second dose level of HM10760A Receives: Drug: HM10760A or placebo |
| Cohort 3 | Experimental | Third dose level of HM10760A Receives: Drug: HM10760A or placebo |
| Cohort 4 | Experimental | Fourth dose level of HM10760A Receives: Drug: HM10760A or placebo |
| Cohort 5 | Experimental | The highest dose level of HM10760A Receives: Drug: HM10760A or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and endogenous erythropoietin level.
Measured: 84 days after the investigational drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionJan 2011
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 Hanmi Pharmaceutical Company LimitedThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030315
- Sponsor's protocol ID
- 09-HM10760A-101
- Acronym
- EPO
- Status last verified
- Feb 2014
- First submitted
- 10 Dec 2009
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Sequential Dose Escalation Study of the Safety, Pharmacodynamics and Pharmacokinetics of Single Intravenous Doses of HM10760A in Healthy Adult Caucasian and Japanese Subjects
- ClinicalTrials.gov ID
- NCT01030315
- Acronym / sponsor ID
- EPO / 09-HM10760A-101
- Conditions
- Healthy
- Keywords
- Erythropoietin, Long-acting, EPO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 11 Dec 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.
Study design:
- Phase I, first-in-human, randomized, double-blind, placebo-controlled, sequential dose escalation study of intravenously administered HM10760A in healthy adult Caucasian and Japanese subjects. Up to 5 dose level cohorts are planned. In each dose level cohort, subjects will be randomized to receive a single dose of HM10760A or placebo.
Primary Objective:
- To evaluate safety profile of single intravenous (IV) dose levels of HM10760A in healthy adult Caucasian and Japanese subjects.
Detailed description
Secondary Objectives:
- To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters
- To assess the immunogenicity of a single IV dose of HM10760A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HM10760A or placeboThe lowest dose level of HM10760A |
| Cohort 2 | Experimental | Drug: HM10760A or placeboSecond dose level of HM10760A |
| Cohort 3 | Experimental | Drug: HM10760A or placeboThird dose level of HM10760A |
| Cohort 4 | Experimental | Drug: HM10760A or placeboFourth dose level of HM10760A |
| Cohort 5 | Experimental | Drug: HM10760A or placeboThe highest dose level of HM10760A |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Caucasian and Japanese male and/or female volunteers
- Age 18 to 55 years
- Hemoglobin of >12 g/dL and <16 g/dL for male subjects, >10 g/dL and <14 g/dL for female Caucasian subjects
Key exclusion criteria (6 listed)
- Prior exposure to EPO, darbepoetin, other EPO support proteins
- hypersensitivity to EPO, darbepoetin, E.coli derived proteins
- Hemoglobinopathy
- SBP > 140 mmHg or < 90 mmHg or DBP > 95 mmHg
- Chronic, uncontrolled, or symptomatic inflammatory disease
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 |
|---|---|---|
| HM10760A or placeboOnce, 0.04 mcg/kg to 2.0mcg/kg once intravenously | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and endogenous erythropoietin level.
Time frame: 84 days after the investigational 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 26 Feb 2014.
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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.
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 of Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
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 6 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 26 Feb 2014. 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 United States. 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?
Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and endogenous erythropoietin level. (time frame: 84 days after the investigational drug administration.). 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 26 Feb 2014.