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A Study of Subcutaneous Doses of HIP2B in Healthy Male Subjects

NCT01638611 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-11-15

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

DRUG

Placebo

Equal volumes of placebo will be given by subcutaneous injection in the abdomen to 2 randomized subjects per dosing cohort.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • CureDM

    lead INDUSTRY

Principal Investigators

  • Scott Rasmussen, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01638611 on ClinicalTrials.gov