NCT00116168

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528

A Phase I, Open Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 19 Years – 49 Years
• Healthy volunteers: Accepted

Summary

A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.

Detailed description

The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single SC doses of MEDI-528 administered to healthy adult volunteers in four dose groups.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-528 0.3 mg/kg	MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
BIOLOGICAL	MEDI-528 1 mg/kg	MEDI-528 (1 mg/kg) administered as a single, SC dose
BIOLOGICAL	MEDI-528 3 mg/kg	MEDI-528 (3 mg/kg) administered as a single, SC dose
BIOLOGICAL	MEDI-528 9 mg/kg	MEDI-528 (9 mg/kg) administered as a single, SC dose

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-04-01
• Completion: 2006-07-01
• First posted: 2005-06-28
• Last updated: 2013-12-11
• Results posted: 2013-12-11

Locations

2 sites across 1 country: United States