HealthyPhase 1HIP2BNCT01638611
A Study of Subcutaneous Doses of HIP2B in Healthy Male Subjects
A Phase 1 study testing HIP2B in people with Healthy, run by CureDM at 1 site in United States.
Trial summary
HIP2B is the stabilized form of the Human proIslet Peptide (HIP). Human proIslet Peptide is the human homolog of Islet Neogenesis Associated Protein (INGAP) peptide, which has shown signals of efficacy in type 1 and type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HIP2B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2012
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a healthy, male, between 19 and 45 years inclusive.
- Subject's body weight is between 50.0 and 100.0 kg inclusive and body mass index (BMI) is between 18.0 and 31.6 kg/m2 inclusive.
- Subject is certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination) by the study doctor.
- Subject has normal vital signs after 10 minutes resting in supine position:
- 95 mmHg ≤ systolic blood pressure ≤ 140 mmHg
- 45 mmHg ≤ diastolic blood pressure ≤ 90 mmHg
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- 40 beats per minute ≤ heart rate ≤100 beats per minute
- Subject has a normal standard 12-lead ECG after 10 minutes resting in supine position; 120 ms < PR < 220 ms, QRS < 120 ms, QTc ≤ 450 ms. Subject must be fasting.
- Laboratory parameters for the subject are within the normal range (or defined screening threshold for the Investigative site), unless the Investigator considers an abnormality to be not clinically significant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (AST/ ALT, amylase, lipase, and fractional bilirubin (direct and indirect) should not exceed the upper laboratory norm).
- Male subjects must continue to use their approved contraceptive method and to refrain from donating semen for 30 days after participating in the study.
- The subject has given written informed consent prior to any study related procedures being performed.
- The subject is not under any administrative or legal supervision.
Who cannot join
- The subject has any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- The subject has frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- The subject has significant blood loss or blood donation, within 56 days prior to IP administration.
- The subject exhibits symptomatic hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure ≥ 20 mmHg within 3 minutes when changing from the supine to the standing position.
- The subject has the presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- The subject has a history or presence of drug or alcohol abuse (alcohol consumption > 2 drinks per day).
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- The subject smokes more than 5 cigarettes or equivalent per day, unable to stop smoking during the days the subject is confined or returning for study related testing.
- Excessive consumption of beverages with xanthine bases (> 4 8 ounce glasses per day) including energy drinks, weight loss drinks, protein mixes (i.e. for body building), etc.
- Any medication, herbal supplement or other natural products (including St John's Wort) within 14 days before the Day 1 visit or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever is longest; any vaccination within the last 28 days. This includes taking analgesics 2 days before Day 1 visit which will interfere with pain assessment.
- Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development.
- Any subject participating in another clinical trial of an investigational therapy (including placebo) within 30 days of screening or 5 half-lives of the study medication, whichever is longer.
- Any subject who cannot be contacted in case of emergency.
- Any subject who is the Investigator or any Sub-Investigator, Research Assistant, Pharmacist, Study Coordinator, or other staff thereof, directly involved in the conduct of the protocol.
- Any subject with a history or presence of any skin condition that would interfere with injection site assessments (including tattoos) and no umbilical piercings.
- Positive results on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive urine ethanol test.
- Any subject with either amylase or lipase levels above the upper laboratory norm
- Any subject with previous history of pancreatitis or known gallbladder disease (including gallstones and gallstone attacks; gallbladder removal will not exclude subject from participating).
- Any subject with prior exposure to INGAP peptide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Third Party (Sponsor) Open, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Single Ascending Subcutaneous Doses of HIP2B in Healthy Male Subjects
HIP2B is the stabilized form of the Human proIslet Peptide (HIP). Human proIslet Peptide is the human homolog of Islet Neogenesis Associated Protein (INGAP) peptide, which has shown signals of efficacy in type 1 and type 2 diabetes mellitus. In a mouse model of diabetes, repeat dose treatment with HIP results in new islet formation and improvement in blood glucose measurements.
HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.
The present clinical trial protocol proposes the first administration of HIP2B to humans with the goal of exploring the tolerability, safety and PK of HIP2B following subcutaneous single ascending doses.
Read the detailed description
Primary Outcome:
To assess the tolerability and safety after subcutaneous single ascending doses of HIP2B in healthy male subjects. Adverse events including local injection site reactions/pain will be assessed during the study. Ongoing adverse events will be followed to resolution or for 30 days (whichever is sooner). Clinical laboratory evaluations including amylase and lipase will be reviewed. Vital signs and ECGs will be used to evaluate subject safety.
Secondary Outcome:
To assess the pharmacokinetics (including Cmax, AUClast, AUC0-∞, tmax, t1/2, tlag) in healthy male subjects after subcutaneous single ascending doses of HIP2B.
- Conditions
- Healthy
- Being tested
- HIP2B, Placebo
- Keywords
- Healthy male volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP2BDrug
Total daily doses of 60, 120, 240, 480, and 720 mg are planned in five separate dosing cohorts. Single or split dose (depending on dose volume) will be given by subcutaneous injection in the abdomen to six subjects per dosing cohort.
PlaceboDrug
Equal volumes of placebo will be given by subcutaneous injection in the abdomen to 2 randomized subjects per dosing cohort.
| Study group | Role | What they receive |
|---|---|---|
| HIP2B | Active comparator | Six subjects per dosing cohort will receive HIP2B Receives: Drug: HIP2B |
| Placebo | Placebo comparator | Two subjects per dosing cohort will receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the tolerability and safety after subcutaneous single ascending doses of HIP2B.
The dose escalation will be guided by safety and tolerability (includes AEs, medical assessments, clinical lab evaluation, and PK). Starting with a dose of 60 mg, a decision to proceed to the next higher "n+1" dose will be made jointly by the Medical Monitor, Sponsor and the Investigator based on blinded safety and tolerability data up to at least 24 hours post dose (Day 2) of at least 6 out of 8 subjects of dose level cohort "n".
Measured: Each dosing cohort will have a study duration of 7 days (±2 days). PK data will be reviewed 11 days after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureDM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Scott Rasmussen, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638611
- Sponsor's protocol ID
- TDU11656
- Acronym
- HIP2B
- Status last verified
- Nov 2016
- First submitted
- 3 Jul 2012
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Third Party (Sponsor) Open, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Single Ascending Subcutaneous Doses of HIP2B in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01638611
- Acronym / sponsor ID
- HIP2B / TDU11656
- Conditions
- Healthy
- Keywords
- Healthy male volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CureDMIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Jul 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.
HIP2B is the stabilized form of the Human proIslet Peptide (HIP). Human proIslet Peptide is the human homolog of Islet Neogenesis Associated Protein (INGAP) peptide, which has shown signals of efficacy in type 1 and type 2 diabetes mellitus. In a mouse model of diabetes, repeat dose treatment with HIP results in new islet formation and improvement in blood glucose measurements.
HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus.
The present clinical trial protocol proposes the first administration of HIP2B to humans with the goal of exploring the tolerability, safety and PK of HIP2B following subcutaneous single ascending doses.
Detailed description
Primary Outcome:
To assess the tolerability and safety after subcutaneous single ascending doses of HIP2B in healthy male subjects. Adverse events including local injection site reactions/pain will be assessed during the study. Ongoing adverse events will be followed to resolution or for 30 days (whichever is sooner). Clinical laboratory evaluations including amylase and lipase will be reviewed. Vital signs and ECGs will be used to evaluate subject safety.
Secondary Outcome:
To assess the pharmacokinetics (including Cmax, AUClast, AUC0-∞, tmax, t1/2, tlag) in healthy male subjects after subcutaneous single ascending doses of HIP2B.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIP2B | Active comparator | Drug: HIP2BSix subjects per dosing cohort will receive HIP2B |
| Placebo | Placebo comparator | Drug: PlaceboTwo subjects per dosing cohort will receive placebo. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subject is a healthy, male, between 19 and 45 years inclusive.
- Subject's body weight is between 50.0 and 100.0 kg inclusive and body mass index (BMI) is between 18.0 and 31.6 kg/m2 inclusive.
- Subject is certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination) by the study doctor.
- Subject has normal vital signs after 10 minutes resting in supine position:
- Subject has a normal standard 12-lead ECG after 10 minutes resting in supine position; 120 ms < PR < 220 ms, QRS < 120 ms, QTc ≤ 450 ms. Subject must be fasting.
Key exclusion criteria (19 listed)
- The subject has any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- The subject has frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- The subject has significant blood loss or blood donation, within 56 days prior to IP administration.
- The subject exhibits symptomatic hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure ≥ 20 mmHg within 3 minutes when changing from the supine to the standing position.
- The subject has the presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
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 |
|---|---|---|
| HIP2BTotal daily doses of 60, 120, 240, 480, and 720 mg are planned in five separate dosing cohorts. Single or split dose (depending on dose volume) will be given by subcutaneous injection in the abdomen to six subjects per dosing cohort. | Drug | HIP2B |
| PlaceboEqual volumes of placebo will be given by subcutaneous injection in the abdomen to 2 randomized subjects per dosing cohort. | Drug | Placebo |
Primary outcome
To assess the tolerability and safety after subcutaneous single ascending doses of HIP2B.
Time frame: Each dosing cohort will have a study duration of 7 days (±2 days). PK data will be reviewed 11 days after dosing.
The dose escalation will be guided by safety and tolerability (includes AEs, medical assessments, clinical lab evaluation, and PK). Starting with a dose of 60 mg, a decision to proceed to the next higher "n+1" dose will be made jointly by the Medical Monitor, Sponsor and the Investigator based on blinded safety and tolerability data up to at least 24 hours post dose (Day 2) of at least 6 out of 8 subjects of dose level cohort "n".
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 15 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Scott Rasmussen, MD principal investigator
Celerion
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 HIP2B in people with Healthy, run by CureDM 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 12 inclusion and 19 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 15 Nov 2016. 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. 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?
To assess the tolerability and safety after subcutaneous single ascending doses of HIP2B. (time frame: Each dosing cohort will have a study duration of 7 days (±2 days). PK data will be reviewed 11 days after dosing.). 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 15 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.