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A Study of Subcutaneous Doses of HIP2B in Healthy Male Subjects (HIP2B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01638611
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : November 15, 2016
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
CureDM

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Healthy Drug: HIP2B Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Active Comparator: HIP2B
Six subjects per dosing cohort will receive HIP2B
Drug: HIP2B
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.

Placebo Comparator: Placebo
Two subjects per dosing cohort will receive placebo.
Drug: Placebo
Equal volumes of placebo will be given by subcutaneous injection in the abdomen to 2 randomized subjects per dosing cohort.




Primary Outcome Measures :
  1. 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".



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
    • 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.

Exclusion Criteria:

  • 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).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638611


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
CureDM
Celerion
Investigators
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Principal Investigator: Scott Rasmussen, MD Celerion
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Responsible Party: CureDM
ClinicalTrials.gov Identifier: NCT01638611    
Other Study ID Numbers: TDU11656
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by CureDM:
Healthy male volunteers