Healthy SubjectsPhase 1NCT03330327
Molar Potency Study of HM12470 in Healthy Subjects
A Phase 1 study testing HM12470 in people with Healthy Subjects, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HM12470
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2015to 17 Aug 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females must be non-pregnant and non-lactating
- Males must be surgically sterile or using an acceptable contraceptive method
Who cannot join
- Participation in an investigational study within 30 days prior to dosing
- Use of new prescription and non-prescription drugs within 3 weeks preceding the first dosing
Trial locations and contacts
1 site in 1 country.
United States1 site
Hanmi Investigative Site
Chula Vista, California, 91911
About this study
Official title: An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12470 and Regular Human Insulin in Healthy Subjects
This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- HM12470
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM12470Biological
HM12470 is a long-acting insulin analogue
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Intravenous (IV) infusion of HM12470 Receives: Biological: HM12470 |
| Part 2: Sequence 1 | Experimental | Intravenous (IV) infusion of HM12470 Receives: Biological: HM12470 |
| Part 2: Sequence 2 | Experimental | Intravenous (IV) infusion of HM12470 Receives: Biological: HM12470 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period
- Comparison of HM12470 to RHI based on blood glucose profile generated by intravenous infusion
Measured: 1 month
Secondary outcomes (2)
Cmax of HM12470
- Maximum concentration of HM12470 over the entire dosing period
Measured: 1 month
AUC of HM12470
- Area Under the Curve of HM12470 over the entire dosing period
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start30 Mar 2015
- Primary completion17 Aug 2017
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT03330327
- Sponsor's protocol ID
- HM-INS-115-102
- Status last verified
- Oct 2017
- First submitted
- 26 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Fixed-Sequence, Glucose Clamp Study to Compare Molar Potency of HM12470 and Regular Human Insulin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03330327
- Acronym / sponsor ID
- HM-INS-115-102
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
This is a phase 1 study to assess and compare molar potency of HM12470 and regular human insulin in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Biological: HM12470Intravenous (IV) infusion of HM12470 |
| Part 2: Sequence 1 | Experimental | Biological: HM12470Intravenous (IV) infusion of HM12470 |
| Part 2: Sequence 2 | Experimental | Biological: HM12470Intravenous (IV) infusion of HM12470 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females must be non-pregnant and non-lactating
- Males must be surgically sterile or using an acceptable contraceptive method
Key exclusion criteria (2 listed)
- Participation in an investigational study within 30 days prior to dosing
- Use of new prescription and non-prescription drugs within 3 weeks preceding the first dosing
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 |
|---|---|---|
| HM12470HM12470 is a long-acting insulin analogue | Biological | Part 1, Part 2: Sequence 1, Part 2: Sequence 2 |
Primary outcome
Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period
Time frame: 1 month
- Comparison of HM12470 to RHI based on blood glucose profile generated by intravenous infusion
2 secondary outcomes
Cmax of HM12470
Time frame: 1 month
AUC of HM12470
Time frame: 1 month
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 6 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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 HM12470 in people with Healthy Subjects, 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 2 inclusion and 2 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 6 Nov 2017. 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?
Blood glucose assessment of HM12470 and regular human insulin (RHI) over the entire dosing period (time frame: 1 month). 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 6 Nov 2017.