HealthyPhase 1NCT01093742
A Study of HM10560A in Healthy Male Subject
A Phase 1 study testing HM10560A 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. Four ascending dose cohorts. In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control). Read more about this study
- Who is it for?
- Ages 20 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HM10560A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Aug 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 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, age range 20 to 54 years are informed of the investigational nature of this study and voluntarily agrees to participate in this study
- Body mass index of ≥19 and ≤26 Subject
- Medically healthy with no clinically significant screening results through Physical examination, 12 lead ECG, Laboratory test
- Able to participate in all procedure
- SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 50-90 times/min
- AST, ALT <1.5 X UNL, CPK < 2 X UNL
- Able to abstain from alcohol and smoke during study period
- Consented to contraception until 2 month after end of the study
Who cannot join
- Acute infection history within 14 days
- Prior exposure or hypersensitivity to recombinant human growth hormone
- Positive findings on HBsAg, Anti-HAV IgM, anti-HCV, HIV Ag, HIV Ab and syphilis high quality regain test
- History of significant gastrointestinal, cardiac, pulmonary, hepato- and nephro- disease
- psychiatric disorder, malignancy tumor, hormonal disorder, diabetes mellitus and hypertension or history of immunosuppressant treatment
- Caffeine, alcohol and smoke abuse
Show all 13Show fewer
- History of hemophilia or anticoagulant treatment
- Revulsion and/or panic about syringe needle and hypersensitivity to subcutaneously administration
- History drug abuse or positive testing for amphetamine, barbiturate, cocaine, opiates, benzodiazepines
- Blood donation or significant blood loss within 60 days prior to Day 1. Plasma donation or transfusion within 30 days prior to Day 1.
- Receipt of another investigational medication within 60 days prior to Day 1
- Use of any herbal products within 30 days or prescription medication within 14 days or over-the-counter medication within 7 days prior to the Day 1.
- Subjects who are unlikely to comply with the protocol requirements, instructions and study related restrictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM10560A After S.C. Administration in Healthy Male Subjects
- Study Design
- Randomized, Double-blind, Placebo-controlled, escalating single-dose design.
- Four ascending dose cohorts.
- In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control).
- Objectives
- The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10560A in healthy male subjects.
Read the detailed description
The secondary objectives of the study are as follows:
- To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous dose of HM10560A.
- Conditions
- Healthy
- Being tested
- HM10560A, Placebo
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM10560ADrug
Subcutaneously administrate at 0 hour on Day 1
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Experimental | HM10560A 0.089 mg/kg or Placebo Receives: Drug: HM10560A; Drug: Placebo |
| cohort 2 | Experimental | HM10560A 0.179 mg/kg or Placebo Receives: Drug: HM10560A; Drug: Placebo |
| cohort 3 | Experimental | HM10560A 0.357 mg/kg or Placebo Receives: Drug: HM10560A; Drug: Placebo |
| cohort 4 | Experimental | HM10560A 0.714 mg/kg or Placebo Receives: Drug: HM10560A; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Investigate Safety of HM10560A:
- Physical examination, Laboratory test, ECG, Vital sign, Adverse event, Local tolerability
Measured: 1, 2, 3, 5, 7, 11, 15, 22, 29 day after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionAug 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jahon Kang, Study director, Hanmi pharma.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093742
- Sponsor's protocol ID
- HM-GHA-101
- Status last verified
- Feb 2014
- First submitted
- 25 Mar 2010
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
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 Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM10560A After S.C. Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01093742
- Acronym / sponsor ID
- HM-GHA-101
- Conditions
- Healthy
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 26 Mar 2010 (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.
- Four ascending dose cohorts.
- In each cohort, subjects will be randomized to receive a single dose of HM10560A or placebo (negative control).
- Objectives
- The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10560A in healthy male subjects.
Detailed description
The secondary objectives of the study are as follows:
- To assess the pharmacokinetics(PK) and pharmacodynamics(PD) of a single subcutaneous dose of HM10560A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Drug: HM10560A, Drug: PlaceboHM10560A 0.089 mg/kg or Placebo |
| cohort 2 | Experimental | Drug: HM10560A, Drug: PlaceboHM10560A 0.179 mg/kg or Placebo |
| cohort 3 | Experimental | Drug: HM10560A, Drug: PlaceboHM10560A 0.357 mg/kg or Placebo |
| cohort 4 | Experimental | Drug: HM10560A, Drug: PlaceboHM10560A 0.714 mg/kg or Placebo |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male volunteers, age range 20 to 54 years are informed of the investigational nature of this study and voluntarily agrees to participate in this study
- Body mass index of ≥19 and ≤26 Subject
- Medically healthy with no clinically significant screening results through Physical examination, 12 lead ECG, Laboratory test
- Able to participate in all procedure
- SBP 90-140 mmHg, DBP 60-90 mmHg, Pulse rate 50-90 times/min
Key exclusion criteria (13 listed)
- Acute infection history within 14 days
- Prior exposure or hypersensitivity to recombinant human growth hormone
- Positive findings on HBsAg, Anti-HAV IgM, anti-HCV, HIV Ag, HIV Ab and syphilis high quality regain test
- History of significant gastrointestinal, cardiac, pulmonary, hepato- and nephro- disease
- psychiatric disorder, malignancy tumor, hormonal disorder, diabetes mellitus and hypertension or history of immunosuppressant treatment
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 |
|---|---|---|
| HM10560ASubcutaneously administrate at 0 hour on Day 1 | Drug | cohort 1, cohort 2, cohort 3, cohort 4 |
| PlaceboPlacebo | Drug | cohort 1, cohort 2, cohort 3, cohort 4 |
Primary outcome
Safety
Time frame: 1, 2, 3, 5, 7, 11, 15, 22, 29 day after administration
Investigate Safety of HM10560A: * Physical examination, Laboratory test, ECG, Vital sign, Adverse event, Local tolerability
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.
Jahon Kang study director
Hanmi pharma.
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 HM10560A 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 8 inclusion and 13 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 (time frame: 1, 2, 3, 5, 7, 11, 15, 22, 29 day after 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 7 Feb 2014.