NCT00192296

Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528.

Detailed description

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

Conditions

• Asthma

Interventions

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

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-02-01
• Completion: 2005-03-01
• First posted: 2005-09-19
• Last updated: 2014-03-06
• Results posted: 2014-03-06

Locations

1 site across 1 country: United States