HealthyPhase 1NCT01093729
A Study of HM11260C in Healthy Male Subject
A Phase 1 study testing HM11260C in people with Healthy, run by Hanmi Pharmaceutical Company Limited.
Trial summary
Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HM11260C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Oct 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, age range 20 to 45 years
- Weight>50 and < 90kg, Body mass index of >18 and <27 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study
Who cannot join
- Acute disease within 1 month prior to start of study drug administration
- Has previously disease which affect drug absorption, distribution, metabolism, excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic disease, renal disease)
- History or presence of clinically significant and active cardiovascular, pulmonary, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor
- Has unsuitable clinical test results through the medical checkup, within 35 days prior to start of administration of study drug (medical history, physical examination, ECG, laboratory test)
- Laboratory test results
- AST (sGOT) or ALT (sGPT) > 1.25Xupper normal limit
Show all 16Show fewer
- Total bilirubin > 1.5Xupper normal limit
- Absolute Neutrophil Count < 1500 mm2
- History or presence of clinically significant allergic disease (including mild allergic rhinitis and allergic dermatitis which is not necessary to medication)
- Prior exposure to products related to Exenatide
- Use of any prescription medication within 14 days prior to Day 1
- Use of any medication within 7 days prior to Day 1 (over-the-counter medication, herbal products, nutrient, vitamins)
- Subject who can't eat standard meal received by Korea University Anam Hospital
- Donor of whole blood for transfusion within 60 days prior to start of study drug administration or donor of apheresis within 20 days or Receiver of blood transfusion within 1 month
- Participation in another clinical study within 60 days prior to start of study drug administration
- Taking Caffein(> 5cups/ day) or alcohol abuse (> 30g/ day) or excessive smoker(> 10 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study
About this study
Official title: A Dose Block-randomized, Double-blind, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM11260C After Subcutaneous Administration in Healthy Male Subjects
Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.
Read the detailed description
Primary Objective: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single subcutaneous dose of HM11260C in healthy male subjects.
- Conditions
- Healthy
- Being tested
- HM11260C
- Keywords
- Exendin-4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM11260CDrug
HM11260C 0.5mcg/kg or Placebo
HM11260CDrug
HM11260C 2mcg/kg or Placebo
HM11260CDrug
HM11260C 4mcg/kg or Placebo
HM11260CDrug
HM11260C 8mcg/kg or Placebo
HM11260CDrug
HM11260C 14mcg/kg or Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort1 | Experimental | HM11260C 0.5mcg/kg or Placebo Receives: Drug: HM11260C |
| Cohort2 | Experimental | HM11260C 2mcg/kg or Placebo Receives: Drug: HM11260C |
| Cohort3 | Experimental | HM11260C 4mcg/kg or Placebo Receives: Drug: HM11260C |
| Cohort4 | Experimental | HM11260C 8mcg/kg or Placebo Receives: Drug: HM11260C |
| Cohort5 | Experimental | HM11260C 14mcg/kg or Placebo Receives: Drug: HM11260C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Investigate Safety of HM10560A: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity
Measured: 1, 2, 3, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day
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 startFeb 2010
- Primary completionOct 2010
- Study completionOct 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
- 41 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, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093729
- Sponsor's protocol ID
- HM-EXC-101
- Status last verified
- Dec 2011
- First submitted
- 23 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, Single Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of HM11260C After Subcutaneous Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01093729
- Acronym / sponsor ID
- HM-EXC-101
- Conditions
- Healthy
- Keywords
- Exendin-4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 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. Five ascending dose cohorts are planned.
Detailed description
Primary Objective: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single subcutaneous dose of HM11260C in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort1 | Experimental | Drug: HM11260CHM11260C 0.5mcg/kg or Placebo |
| Cohort2 | Experimental | Drug: HM11260CHM11260C 2mcg/kg or Placebo |
| Cohort3 | Experimental | Drug: HM11260CHM11260C 4mcg/kg or Placebo |
| Cohort4 | Experimental | Drug: HM11260CHM11260C 8mcg/kg or Placebo |
| Cohort5 | Experimental | Drug: HM11260CHM11260C 14mcg/kg or Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers, age range 20 to 45 years
- Weight>50 and < 90kg, Body mass index of >18 and <27 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study
Key exclusion criteria (16 listed)
- Acute disease within 1 month prior to start of study drug administration
- Has previously disease which affect drug absorption, distribution, metabolism, excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic disease, renal disease)
- History or presence of clinically significant and active cardiovascular, pulmonary, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor
- Has unsuitable clinical test results through the medical checkup, within 35 days prior to start of administration of study drug (medical history, physical examination, ECG, laboratory test)
- Laboratory test results
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 |
|---|---|---|
| HM11260CHM11260C 0.5mcg/kg or Placebo | Drug | Cohort1 |
| HM11260CHM11260C 2mcg/kg or Placebo | Drug | Cohort2 |
| HM11260CHM11260C 4mcg/kg or Placebo | Drug | Cohort3 |
| HM11260CHM11260C 8mcg/kg or Placebo | Drug | Cohort4 |
| HM11260CHM11260C 14mcg/kg or Placebo | Drug | Cohort5 |
Primary outcome
Safety
Time frame: 1, 2, 3, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day
Investigate Safety of HM10560A: Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity
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
Korea
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HM11260C in people with Healthy, run by Hanmi Pharmaceutical Company Limited.
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 16 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.
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, 4, 5, 7, 9, 16, 22, 30, 36, 43, 57, 84 Day). 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.