HealthyPhase 1HM12460ANCT01724814
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A
A Phase 1 study testing HM12460A in people with Healthy and Type 1 Diabetes Mellitus, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
Study Design: Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1 diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- What is being tested?
- HM12460A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2012to 1 Jul 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Age ≥18 and ≤70 years
- Non-obese; body mass index between 18.0 and 30.0 kg/m2 inclusive.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- Non-smoker, or light smoker, defined as <15 cigarettes/day and able to abstain from smoking during confinement period.
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
Who cannot join
- Previous participation in this trial or other clinical trials within the last 3 months.
- Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, healthy subjects with liver enzymes above the upper limit of the normal range and subjects with diabetes who have elevated liver enzymes (AST or ALT >2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will be excluded.
- History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- Clinically significant abnormal ECG at screening, as judged by the Investigator.
- History of alcohol abuse.
- Any positive reaction of drugs of abuse.
- Hepatitis B or C or HIV positive.
- Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for medications deemed acceptable per protocol specific list of concomitant medications.
Trial locations and contacts
1 site in 1 country.
About this study
Study Design:
Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1 diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes
Read the detailed description
The principle objectives of this study are to assess safety and tolerability and to explore pharmacokinetic(PK) and pharmacodynamic(PD) parameters of a single dose of a novel very-long acting insulin formulation (HM12460A) in comparison to a single dose of human Neutral Protamine Hagedorn (NPH) in healthy volunteers (part 1), subjects with type 1 diabetes (part 2) and in subjects with type 2 diabetes (part 3).
The study will incorporate adaptive elements to provide both PK and PD data. The dose of HM12460A to be administered to the subjects with type 1 diabetes and type 2 diabetes will be guided by PK data from part 1 of the study; the PD assessment of HM12460A in subjects with diabetes will also be informed by knowledge of PK gained from the healthy volunteer study.
- Conditions
- Healthy, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- HM12460A, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM12460ADrug
Also called LAPS-Insulin
Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A
PlaceboDrug
Singe dose SC administration of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort S1 | Experimental | HM12460A Dose 1 (1.2 nmol/kg) or placebo Receives: Drug: HM12460A; Drug: Placebo |
| Cohort S2 | Experimental | HM12460A Dose 2 (2.4 nmol/kg) or Placebo Receives: Drug: HM12460A; Drug: Placebo |
| Cohort S3 | Experimental | HM12460A Dose 3 (4.8 nmol/kg) or Placebo Receives: Drug: HM12460A; Drug: Placebo |
| Cohort S4 | Experimental | HM12460A Dose 4 (9.6 nmol/kg) or Placebo Receives: Drug: HM12460A; Drug: Placebo |
| Cohort S5 | Experimental | HM12460A Dose 5 (14.4 nmol/kg) or Placebo Receives: Drug: HM12460A; Drug: Placebo |
| Cohort S6 | Experimental | HM12460A Dose 6 (19.2 nmol/kg) or Placebo Receives: Drug: HM12460A; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent adverse events
Measured: one year
Secondary outcomes (1)
Peak Plasma Concentration(Cmax) of HM12460A following a single dose in Parts 1-3
PK properties of HM12460A following a single dose in Parts 1-3 will be assessed in plasma using a validated assay
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study start20 Dec 2012
- Primary completion1 Jul 2014
- Study completion1 Jul 2014
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.
- 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
- 86 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
- NCT01724814
- Sponsor's protocol ID
- HM-INS-101
- Acronym
- HM12460A
- Status last verified
- Nov 2017
- First submitted
- 5 Nov 2012
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12460A
- ClinicalTrials.gov ID
- NCT01724814
- Acronym / sponsor ID
- HM12460A / HM-INS-101
- Conditions
- Healthy, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2012 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Jul 2014 (actual)
- First posted
- 12 Nov 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:
Part 1.Randomized, double-blind, placebo-controlled, escalating single-dose design with Healthy volunteers Part 2.Open , sequential, two-period, single dose study with type 1 diabetes Part 3.Open, sequential, two-period, single dose study with type 2 diabetes
Detailed description
The principle objectives of this study are to assess safety and tolerability and to explore pharmacokinetic(PK) and pharmacodynamic(PD) parameters of a single dose of a novel very-long acting insulin formulation (HM12460A) in comparison to a single dose of human Neutral Protamine Hagedorn (NPH) in healthy volunteers (part 1), subjects with type 1 diabetes (part 2) and in subjects with type 2 diabetes (part 3).
The study will incorporate adaptive elements to provide both PK and PD data. The dose of HM12460A to be administered to the subjects with type 1 diabetes and type 2 diabetes will be guided by PK data from part 1 of the study; the PD assessment of HM12460A in subjects with diabetes will also be informed by knowledge of PK gained from the healthy volunteer study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort S1 | Experimental | Drug: HM12460A, Drug: PlaceboHM12460A Dose 1 (1.2 nmol/kg) or placebo |
| Cohort S2 | Experimental | Drug: HM12460A, Drug: PlaceboHM12460A Dose 2 (2.4 nmol/kg) or Placebo |
| Cohort S3 | Experimental | Drug: HM12460A, Drug: PlaceboHM12460A Dose 3 (4.8 nmol/kg) or Placebo |
| Cohort S4 | Experimental | Drug: HM12460A, Drug: PlaceboHM12460A Dose 4 (9.6 nmol/kg) or Placebo |
| Cohort S5 | Experimental | Drug: HM12460A, Drug: PlaceboHM12460A Dose 5 (14.4 nmol/kg) or Placebo |
| Cohort S6 | Experimental | Drug: HM12460A, Drug: PlaceboHM12460A Dose 6 (19.2 nmol/kg) or Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy subjects
- Age ≥18 and ≤70 years
- Non-obese; body mass index between 18.0 and 30.0 kg/m2 inclusive.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- Non-smoker, or light smoker, defined as <15 cigarettes/day and able to abstain from smoking during confinement period.
Key exclusion criteria (8 listed)
- Previous participation in this trial or other clinical trials within the last 3 months.
- Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, healthy subjects with liver enzymes above the upper limit of the normal range and subjects with diabetes who have elevated liver enzymes (AST or ALT >2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will be excluded.
- History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- Clinically significant abnormal ECG at screening, as judged by the Investigator.
- History of alcohol abuse.
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 |
|---|---|---|
| HM12460AAlso: LAPS-InsulinSingle dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A | Drug | Cohort S1, Cohort S2, Cohort S3, Cohort S4, Cohort S5, Cohort S6 |
| PlaceboSinge dose SC administration of Placebo | Drug | Cohort S1, Cohort S2, Cohort S3, Cohort S4, Cohort S5, Cohort S6 |
Primary outcome
Incidence and severity of treatment emergent adverse events
Time frame: one year
1 secondary outcome
Peak Plasma Concentration(Cmax) of HM12460A following a single dose in Parts 1-3
Time frame: one year
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 8 Nov 2017.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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 HM12460A in people with Healthy and Type 1 Diabetes Mellitus, 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 7 inclusion and 8 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 8 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?
Incidence and severity of treatment emergent adverse events (time frame: one year). 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 8 Nov 2017.