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drugset / Trial / NCT00820885

A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide

NCT00820885 ↗

Phase 1 Completed 95 enrolled Shire
RandomizedSingle-groupTriple-blindOther

Summary

The primary objective of the study was to study the safety and tolerability of teduglutide following a once or possibly twice daily subcutaneous injection for eight consecutive days in healthy subjects. A secondary objective was to study the pharmacokinetics of teduglutide following a once or possibly twice daily injection for eight consecutive days in healthy subjects.

Timeline

Start
2006-09-06
Primary completion
2007-04-23
Completion
2007-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Teduglutide Peptide 10 mg Subcutaneous
Subject Teduglutide Peptide 15 mg Subcutaneous
Subject Teduglutide Peptide 20 mg Subcutaneous
Subject Teduglutide Peptide 25 mg Subcutaneous
Subject Teduglutide Peptide 30 mg Subcutaneous
Subject Teduglutide Peptide 50 mg Subcutaneous
Subject Teduglutide Peptide 80 mg Subcutaneous

Indications

No indication recorded.