HealthyPhase 1NCT01504581
Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects
A Phase 1 study testing HM10660A and Pegasys in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in Netherlands.
Trial summary
Study design: This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HM10660A and Pegasys
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2011to Sep 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 - 45 Years, Inclusive
- BMI: 18.0 - 28.0 kg/m2
- Are Non-smokers or Smoker of Fewer Than 5 Cigarettes Per Day as Determined by History
Who cannot join
- Mental Handicap
- Evidence of Clinically Relevant Pathology
- History of Type 1 Diabetes or Thyroid Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo- And Active-Controlled Study Of The Pharmacokinetics, Pharmacodynamics And Safety Of Single Ascending Doses Of HM10660A (LAPS-INTERFERON ALPHA-2B) In Healthy Male Subjects
Study design:
This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.
Read the detailed description
Primary objective:
to study the safety and tolerability of HM10660A, including immunogenicity, as compared to PEG-interferon alpha-2a
Secondary objective:
to study the pharmacokinetics and pharmacodynamics of HM10660A as compared to PEG-interferon alpha-2a
- Conditions
- Healthy
- Being tested
- HM10660A, HM10660A placebo, Pegasys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM10660ABiological
Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg
HM10660A placeboBiological
Single dose of HM10660A Placebo
PegasysBiological
Single dose of Pegasys 180ug
| Study group | Role | What they receive |
|---|---|---|
| HM10660A | Experimental | Not described Receives: Biological: HM10660A |
| Pegasys | Active comparator | Not described Receives: Biological: Pegasys |
| HM10660A Placebo | Placebo comparator | Not described Receives: Biological: HM10660A placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change among HM10660A receivers will be assessed. It can be compared to those numbers in Active comparator group.
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startMar 2011
- Primary completionSep 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT01504581
- Sponsor's protocol ID
- 11-HM10660A-101
- Status last verified
- Feb 2014
- First submitted
- 27 Dec 2011
- 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 Randomized, Double-Blind, Placebo- And Active-Controlled Study Of The Pharmacokinetics, Pharmacodynamics And Safety Of Single Ascending Doses Of HM10660A (LAPS-INTERFERON ALPHA-2B) In Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01504581
- Acronym / sponsor ID
- 11-HM10660A-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- First posted
- 5 Jan 2012 (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:
This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.
Detailed description
Primary objective:
to study the safety and tolerability of HM10660A, including immunogenicity, as compared to PEG-interferon alpha-2a
Secondary objective:
to study the pharmacokinetics and pharmacodynamics of HM10660A as compared to PEG-interferon alpha-2a
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HM10660A | Experimental | Biological: HM10660A |
| Pegasys | Active comparator | Biological: Pegasys |
| HM10660A Placebo | Placebo comparator | Biological: HM10660A placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18 - 45 Years, Inclusive
- BMI: 18.0 - 28.0 kg/m2
- Are Non-smokers or Smoker of Fewer Than 5 Cigarettes Per Day as Determined by History
Key exclusion criteria (3 listed)
- Mental Handicap
- Evidence of Clinically Relevant Pathology
- History of Type 1 Diabetes or Thyroid 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 |
|---|---|---|
| HM10660ASingle dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg | Biological | HM10660A |
| HM10660A placeboSingle dose of HM10660A Placebo | Biological | HM10660A Placebo |
| PegasysSingle dose of Pegasys 180ug | Biological | Pegasys |
Primary outcome
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change
Time frame: 43 days
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change among HM10660A receivers will be assessed. It can be compared to those numbers in Active comparator group.
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.
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 testing HM10660A and Pegasys in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in Netherlands.
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 3 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change (time frame: 43 days). 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.