At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
Recombinant human hyaluronidase PH20 (rHuPH20) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1, Randomized, Double-Blind, Pharmacokinetic and Glucodynamic, 6-Way Crossover Study of Subcutaneously Administered Insulin Analogs With Recombinant Human Hyaluronidase (rHuPH20) Compared to Insulin Analogs Alone in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Recombinant human hyaluronidase PH20 (rHuPH20), Insulin lispro, and 2 other interventions for Healthy. Completed, enrolled 14 participants across 1 site.
Detailed Summary
This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedSep 2009
Primary CompletionFeb 2010
Study CompletionMay 2010
TodayJul 2026
First PostedSep 18, 2009
Enrollment StartSep 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.8 years ago
Interventions
Recombinant human hyaluronidase PH20 (rHuPH20)drug
Insulin lisprodrug
Insulin glulisinedrug
Insulin aspartdrug