CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 253 enrolled
Drug / intervention
Hyaluronidase +2 moredrug
Likely dose
Hyaluronidase 0.02 mLfrom 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.

Search/NCT01689363
NCT01689363Phase 2Completed
CompareCT.gov

A Randomized, Double-Blinded, Negative- and Positive-Controlled Study for Evaluation of the Allergenicity of Amphadase® in Healthy Volunteers Using Intradermal Skin Test

Amphastar Pharmaceuticals, Inc.·interventional·Posted Sep 21, 2012·Updated Jan 20, 2017

In Brief

A Phase 2 clinical trial evaluating Hyaluronidase, Histamine, and 1 other intervention for Allergic Skin Reaction. Completed, enrolled 253 participants across 5 sites.

Detailed Summary

This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Skin Reaction
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 21, 2012
Enrollment StartSep 1, 2012
Primary CompletionNov 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.8 years ago

Interventions

Hyaluronidasedrug

Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.

Histaminedrug

Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.

Salinedrug

Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.