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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
40
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.
Equal volumes of placebo will be given by subcutaneous injection in the abdomen to 2 randomized subjects per dosing cohort.
Celerion
Lincoln, Nebraska, United States
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".
Time frame: Each dosing cohort will have a study duration of 7 days (±2 days). PK data will be reviewed 11 days after dosing.
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