HealthyPhase 1NCT00998283
Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects
A Phase 1 study testing HM10460A 5μg/kg, HM10460A 15μg/kg and HM10460A 45μg/kg in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
Study Design Randomized, Double-blind, Placebo-controlled, escalating single-dose design. Five ascending dose cohorts. In each cohort, subjects will be randomized to receive a single dose of HM10460A or placebo (negative control) Objectives The primary objective of the study is to assess the safety and tolerability of… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HM10460A 5μg/kg, HM10460A 15μg/kg and HM10460A 45μg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Sep 2010
- 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
- Healthy adult Korean male and/or females, 20 - 45 years of age(inclusive).
- BMI of 18 - 27kg/m2.
- Medically healthy with no clinically significant screening results.
- The following results in laboratory test
- Absolute neutrophil count (ANC) : 2000 ~ 7500/mm3
- Non-smokers or subjects who smoke less than 10 cigarettes/day
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- After a confirmed menstrual period, females of childbearing potential must be either sexually inactive (abstinent) for 14 days prior to screening and agree to remain so throughout the study, or have been using a highly effective method of birth control, such as the following examples:
- intra-uterine device in place for at least 3 months prior to Day 1;
- stable hormonal contraceptive for at least 3 months prior to Day 1 through completion of study;
- surgical sterilization (vasectomy) of partner at least 6 months prior to Day 1.
- Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1:
- bilateral tubal ligation;
- hysterectomy;
- hysterectomy with unilateral or bilateral oophorectomy;
- bilateral oophorectomy.
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 at screening or check-in.
- Positive testing for HIV, HBsAg, or HCV antibodies.
- Active infection
- Positive testing for palpable spleen at screening or check-in.
- The following results in laboratory test:
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- WBC > 10.0 x 10^3/mm3
- Hb < 13g/dL
- Platelet < 150 x 10^3/mm3
- AST/ALT > 50 IU/L
- History or presence of alcoholism or drug abuse within 2 years prior to Day 1.
- History of G-CSF-related product use (i.e., pegfilgrastim, filgrastim).
- History of anaphylactic reaction to medicine or environmental exposures.
- Use of any prescription medication (with the exception of hormonal contraceptives for females) or receipt of any blood products within 14 days prior to Day 1.
- Use of any over-the-counter medication, including herbal products, within 7 days prior to the Day 1. Up to 2 grams per day of acetaminophen is allowed at the discretion of the Investigator.
- Blood donation or significant blood loss within 56 days prior to Day 1.
- Plasma donation within 7 days prior to Day 1.
- Participation in another clinical trial (receipt of last investigational medication) within 30 days prior to Day 1.
- Females who are pregnant or lactating.
- Subjects who are unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Korean Subjects
- Study Design
- Randomized, Double-blind, Placebo-controlled, escalating single-dose design.
- Five ascending dose cohorts.
- In each cohort, subjects will be randomized to receive a single dose of HM10460A or placebo (negative control)
- Objectives
- The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Korean Subjects
Read the detailed description
The secondary objectives of the study are as follows:
- to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.
- 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 (HM10460A, native G-CSF antibody,neutralizing antibodies) of a single subcutaneous dose of HM10460A.
- Conditions
- Healthy
- Being tested
- HM10460A 5μg/kg, HM10460A 15μg/kg, HM10460A 45μg/kg, HM10460A 135μg/kg, HM10460A 350μg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM10460A 5μg/kgDrug
Subcutaneously administrate at 0 hour on Day 1
HM10460A 15μg/kgDrug
Subcutaneously administrate at 0 hour on Day 1
HM10460A 45μg/kgDrug
Subcutaneously administrate at 0 hour on Day 1
HM10460A 135μg/kgDrug
Subcutaneously administrate at 0 hour on Day 1
HM10460A 350μg/kgDrug
Subcutaneously administrate at 0 hour on Day 1
PlaceboDrug
Subcutaneously administrate at 0 hour on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Administration of HM10460A 5μg/kg or Placebo Receives: Drug: HM10460A 5μg/kg; Drug: Placebo |
| Cohort 2 | Experimental | Administration of HM10460A 15μg/kg or placebo Receives: Drug: HM10460A 15μg/kg; Drug: Placebo |
| Cohort 3 | Experimental | Administration of HM10460A 45μg/kg or placebo Receives: Drug: HM10460A 45μg/kg; Drug: Placebo |
| Cohort 4 | Experimental | Administration of HM10460A 135μg/kg or placebo Receives: Drug: HM10460A 135μg/kg; Drug: Placebo |
| Cohort 5 | Experimental | Administration of HM10460A 350μg/kg or placebo Receives: Drug: HM10460A 350μg/kg; Drug: Placebo |
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, and adverse effects (AEs)
Measured: Time point of collection, where appropriate
Samples for immunogenicity
Measured: Time point of collection, where appropriate
Secondary outcomes (2)
Serum PK parameters/Urine PK parameters
Measured: Serum : pre-dose, 0.25, 05, 0.75, 1,2,3,4,6,8,12,16,24,36,48,72,96,120,144 (hr)// Urine : 0-6, 6-12, 12-24, 24-36, 36,48(hr)
Calculation of the ANC (Absolute Neutrophil count) & CD34+ cell.
Measured: Pre-dose, 24 and 48 hours post-dose, on return 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 posted20 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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, Seoul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998283
- Sponsor's protocol ID
- 09-HM10460A-102
- Status last verified
- Feb 2014
- First submitted
- 18 Oct 2009
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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-Controlled, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HM10460A (HNK460) When Administered Subcutaneously to Healthy Adult Korean Subjects
- ClinicalTrials.gov ID
- NCT00998283
- Acronym / sponsor ID
- 09-HM10460A-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 Oct 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.
- Five ascending dose cohorts.
- In each cohort, subjects will be randomized to receive a single dose of HM10460A or placebo (negative control)
- Objectives
- The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Korean Subjects
Detailed description
The secondary objectives of the study are as follows:
- to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.
- 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 (HM10460A, native G-CSF antibody,neutralizing antibodies) of a single subcutaneous dose of HM10460A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HM10460A 5μg/kg, Drug: PlaceboAdministration of HM10460A 5μg/kg or Placebo |
| Cohort 2 | Experimental | Drug: HM10460A 15μg/kg, Drug: PlaceboAdministration of HM10460A 15μg/kg or placebo |
| Cohort 3 | Experimental | Drug: HM10460A 45μg/kg, Drug: PlaceboAdministration of HM10460A 45μg/kg or placebo |
| Cohort 4 | Experimental | Drug: HM10460A 135μg/kg, Drug: PlaceboAdministration of HM10460A 135μg/kg or placebo |
| Cohort 5 | Experimental | Drug: HM10460A 350μg/kg, Drug: PlaceboAdministration of HM10460A 350μg/kg or placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy adult Korean male and/or females, 20 - 45 years of age(inclusive).
- BMI of 18 - 27kg/m2.
- Medically healthy with no clinically significant screening results.
- The following results in laboratory test
- Absolute neutrophil count (ANC) : 2000 ~ 7500/mm3
Key exclusion criteria (20 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Positive urine drug/alcohol testing at screening or check-in.
- Positive testing for HIV, HBsAg, or HCV antibodies.
- Active infection
- Positive testing for palpable spleen at screening or check-in.
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 5μg/kgSubcutaneously administrate at 0 hour on Day 1 | Drug | Cohort 1 |
| HM10460A 15μg/kgSubcutaneously administrate at 0 hour on Day 1 | Drug | Cohort 2 |
| HM10460A 45μg/kgSubcutaneously administrate at 0 hour on Day 1 | Drug | Cohort 3 |
| HM10460A 135μg/kgSubcutaneously administrate at 0 hour on Day 1 | Drug | Cohort 4 |
| HM10460A 350μg/kgSubcutaneously administrate at 0 hour on Day 1 | Drug | Cohort 5 |
| PlaceboSubcutaneously administrate at 0 hour on Day 1 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs, and adverse effects (AEs)
Time frame: Time point of collection, where appropriate
Samples for immunogenicity
Time frame: Time point of collection, where appropriate
2 secondary outcomes
Serum PK parameters/Urine PK parameters
Time frame: Serum : pre-dose, 0.25, 05, 0.75, 1,2,3,4,6,8,12,16,24,36,48,72,96,120,144 (hr)// Urine : 0-6, 6-12, 12-24, 24-36, 36,48(hr)
Calculation of the ANC (Absolute Neutrophil count) & CD34+ cell.
Time frame: Pre-dose, 24 and 48 hours post-dose, on return 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.
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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
Seoul
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 HM10460A 5μg/kg, HM10460A 15μg/kg and HM10460A 45μg/kg in people with Healthy, run by Hanmi Pharmaceutical Company Limited 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 15 inclusion and 20 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 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?
Safety data, including physical examinations (to include injection site reactions and splenic evaluations), laboratory evaluations, ECGs, vital signs, and adverse effects (AEs) (time frame: Time point of collection, 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?
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.