NCT01401764

Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Formulation buffers	Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-07-25
• Last updated: 2013-01-31

Locations

1 site across 1 country: Belgium