drugset
drugset / Trial / NCT00803972

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

NCT00803972 ↗

Phase 1 Completed 42 enrolled Halozyme Therapeutics
RandomizedParallel-groupSingle-blindOther

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic 3 iu Subcutaneous
Subject Insulin Protein / enzyme biologic 6 iu Subcutaneous
Subject Insulin Protein / enzyme biologic 12 iu Subcutaneous
Subject Insulin Protein / enzyme biologic 24 iu Subcutaneous
Subject Insulin Lispro Protein / enzyme biologic 1.5 iu Subcutaneous
Subject Insulin Lispro Protein / enzyme biologic 2 iu Subcutaneous
Subject Insulin Lispro Protein / enzyme biologic 6 iu Subcutaneous
Subject Insulin Lispro Protein / enzyme biologic 20 iu Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 0 ug/ml Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 0.0625 ug/ml Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 0.3125 ug/ml Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 1.25 ug/ml Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 5 ug/ml Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 10 ug/ml Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 20 ug/ml Subcutaneous
Subject rHuPH20 Protein / enzyme biologic 80 ug/ml Subcutaneous

Indications

No indication recorded.