HealthyPhase 1NCT01037543
Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects
A Phase 1 study of Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
Study Design Randomized, double-blind, placebo-controlled, escalating single-dose design. Six ascending dose cohorts In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control). Read more about this study
- Who is it for?
- Ages 20 to 45 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
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Apr 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 18 - 29.9 kg/m2
- have not used tobacco or nicotine containing products for at least 3 months prior to dosing
- be able to remain abstinent throughout the study.
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- positive urine drug/alcohol testing
- Positive for HIV, HBsAg, HCV ab
- History of anaphylactic reaction to medicine or environmental exposure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and PK of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Japanese and Caucasian Subjects.
Study Design
- Randomized, double-blind, placebo-controlled, escalating single-dose design.
- Six ascending dose cohorts
- In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control).
- Primary Objective
- to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.
Read the detailed description
Secondary objectives:
- to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.
- to compare the PK of HM10460A in Japanese and Caucasian subjects.
- to assess the relationship between the serum concentration of HM10460A and absolute neutrophil count (ANC).
- to assess the relationship between the serum concentration of HM10460A and CD34+ cell counts in the blood.
- To assess the immunogenicity potential of HM10460A by measuring binding antibodies (bAb) and neutralizing antibodies (nAb) to HM10460A and native G-CSF following a single subcutaneous dose of HM10460A.
- Conditions
- Healthy
- Being tested
- HM10460A or placebo or Neulasta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM10460A or placebo or NeulastaDrug
Also called LAPS-G-CSF
Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1.1 mcg/kg of HM10460A, placebo, or Neulasta Receives: Drug: HM10460A or placebo or Neulasta |
| Cohort 2 | Experimental | 3.3 mcg/kg HM10460A, placebo or Neulasta Receives: Drug: HM10460A or placebo or Neulasta |
| Cohort 3 | Experimental | 10 mcg/kg of HM10460A, placebo, or Neulasta Receives: Drug: HM10460A or placebo or Neulasta |
| Cohort 4 | Experimental | 30 mcg/kg of HM10460A, placebo, or Neulasta Receives: Drug: HM10460A or placebo or Neulasta |
| Cohort 5 | Experimental | 90 mcg/kg or HM10460A, placebo, or Neulasta Receives: Drug: HM10460A or placebo or Neulasta |
| Cohort 6 | Experimental | 270 mcg/kg of HM10460A, placebo, or Neulasta Receives: Drug: HM10460A or placebo or Neulasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs).
Measured: Time points where appropriate.
Samples for immunogenicity
Measured: Days -1, 15, 22, and 42.
Secondary outcomes (2)
PK parameters measured from Serum and Urine samples.
Measured: Serum samples: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hrs, Days 4, 5, 6, 7, 11, 15, and 22. / Urine Samples: 0 - 6, 6 - 12, 12 - 24, 24 - 36, and 36 - 48 hours post-dose.
Calculation of ANC and CD34+ cell counts.
Measured: pre-dose, 24 and 48 hours post-dose, Days 4, 5, 6, 7, 11, 15, and 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completionApr 2011
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.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanmi Clinical, Principal investigator, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037543
- Sponsor's protocol ID
- 08-HM10460A-101
- Status last verified
- Feb 2014
- First submitted
- 21 Dec 2009
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jeon Y, Lee N, Baek S, Choi J, Jhee S, Lee H. A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects. Drugs R D. 2022 Mar;22(1):71-87. doi: 10.1007/s40268-021-00379-8. Epub 2022 Jan 6.
PubMed 34993933
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and PK of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Japanese and Caucasian Subjects.
- ClinicalTrials.gov ID
- NCT01037543
- Acronym / sponsor ID
- 08-HM10460A-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 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
- Randomized, double-blind, placebo-controlled, escalating single-dose design.
- Six ascending dose cohorts
- In each cohorts, subjects will be randomized to receive a single dose of HM10460A, placebo (negative control), or Neulasta® (positive control).
- Primary Objective
- to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Japanese and Caucasian subjects.
Detailed description
Secondary objectives:
- to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.
- to compare the PK of HM10460A in Japanese and Caucasian subjects.
- to assess the relationship between the serum concentration of HM10460A and absolute neutrophil count (ANC).
- to assess the relationship between the serum concentration of HM10460A and CD34+ cell counts in the blood.
- To assess the immunogenicity potential of HM10460A by measuring binding antibodies (bAb) and neutralizing antibodies (nAb) to HM10460A and native G-CSF following a single subcutaneous dose of HM10460A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HM10460A or placebo or Neulasta1.1 mcg/kg of HM10460A, placebo, or Neulasta |
| Cohort 2 | Experimental | Drug: HM10460A or placebo or Neulasta3.3 mcg/kg HM10460A, placebo or Neulasta |
| Cohort 3 | Experimental | Drug: HM10460A or placebo or Neulasta10 mcg/kg of HM10460A, placebo, or Neulasta |
| Cohort 4 | Experimental | Drug: HM10460A or placebo or Neulasta30 mcg/kg of HM10460A, placebo, or Neulasta |
| Cohort 5 | Experimental | Drug: HM10460A or placebo or Neulasta90 mcg/kg or HM10460A, placebo, or Neulasta |
| Cohort 6 | Experimental | Drug: HM10460A or placebo or Neulasta270 mcg/kg of HM10460A, placebo, or Neulasta |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI of 18 - 29.9 kg/m2
- have not used tobacco or nicotine containing products for at least 3 months prior to dosing
- be able to remain abstinent throughout the study.
Key exclusion criteria (4 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- positive urine drug/alcohol testing
- Positive for HIV, HBsAg, HCV ab
- History of anaphylactic reaction to medicine or environmental exposure
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 |
|---|---|---|
| HM10460A or placebo or NeulastaAlso: LAPS-G-CSFSingle SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs).
Time frame: Time points where appropriate.
Samples for immunogenicity
Time frame: Days -1, 15, 22, and 42.
2 secondary outcomes
PK parameters measured from Serum and Urine samples.
Time frame: Serum samples: pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hrs, Days 4, 5, 6, 7, 11, 15, and 22. / Urine Samples: 0 - 6, 6 - 12, 12 - 24, 24 - 36, and 36 - 48 hours post-dose.
Calculation of ANC and CD34+ cell counts.
Time frame: pre-dose, 24 and 48 hours post-dose, Days 4, 5, 6, 7, 11, 15, and 22.
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 7 Feb 2014.
- Derived from this study: PubMed 34993933Jeon Y, Lee N, Baek S, Choi J, Jhee S, Lee H. A Randomized, Double-Blind, Placebo- and Active-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profiles of Subcutaneous Eflapegrastim in Healthy Japanese and Caucasian Subjects. Drugs R D. 2022 Mar;22(1):71-87. doi: 10.1007/s40268-021-00379-8. Epub 2022 Jan 6.
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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.
Hanmi Clinical principal investigator
California
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 4 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 7 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 (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs assessments, and adverse effects (AEs). (time frame: Time points where appropriate.). The study lists 2 primary outcomes in all. 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 NCT01037543, 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 7 Feb 2014.