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Dose-Ranging, Pharmacokinetic (PK), Glucodynamic (GD), Safety and Tolerability Study of Subcutaneously (SC) Administered Humulin R and Humalog With or Without rHuPH20

NCT00803972 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-08-15

No results posted yet for this study

Summary

This is a single center, Phase I, open-label, single-blind (subjects blinded to the contents of each injection), 4 stage study designed to determine the PK, GD, safety, tolerability, and optimal ratio of rHuPH20 administered with fixed Humulin R or Humalog doses in healthy subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

rHuPH20

recombinant human hyaluronidase PH20

DRUG

Insulin Human Injection

injection

DRUG

Insulin Lispro Injection

injection

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jolene K Berg, MD · dgd Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-08-28
Completion
2009-08-28

Countries

  • United States

Study Locations

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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 NCT00803972 on ClinicalTrials.gov