A Study of Subcutaneous Doses of HIP2B in Healthy Male Subjects (HIP2B)
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|ClinicalTrials.gov Identifier: NCT01638611|
Recruitment Status : Completed
First Posted : July 12, 2012
Last Update Posted : November 15, 2016
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|
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.
To assess the pharmacokinetics (including Cmax, AUClast, AUC0-∞, tmax, t1/2, tlag) in healthy male subjects after subcutaneous single ascending doses of HIP2B.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
Active Comparator: HIP2B
Six subjects per dosing cohort will receive 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.
Equal volumes of placebo will be given by subcutaneous injection in the abdomen to 2 randomized subjects per dosing cohort.
- 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".
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
|United States, Nebraska|
|Lincoln, Nebraska, United States, 68502|
|Principal Investigator:||Scott Rasmussen, MD||Celerion|