CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
MEDI-528 0.3 mg/kg +3 morebiological
Likely dose
MEDI-528 0.3, 1, 3, or 9 mg/kg as single intravenous doseAI-extracted
Key inclusion· 4
  • ✓Age 18 to 49 years at first dose
  • ✓Body weight < 89 kg
  • ✓Healthy by medical history and physical examination
  • ✓Able to complete 84-day follow-up period
Key exclusion· 7
  • ✕Acute illness or active infection (fever ≥38.0°C)
  • ✕Use of prescription medications (except contraceptives) within 28 days before study start
  • ✕History of immunodeficiency or current immunosuppressive therapy including systemic corticosteroids
  • ✕History of allergic disease or reactions to study drug components

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00192296
NCT00192296Phase 1Completed
CompareCT.gov

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

MedImmune LLC·interventional·Posted Sep 19, 2005·Updated Mar 6, 2014

In Brief

A Phase 1 clinical trial evaluating MEDI-528 0.3 mg/kg, MEDI-528 1 mg/kg, and 2 other interventions for Asthma. Completed, enrolled 24 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartAug 1, 2004
Primary CompletionFeb 1, 2005
Study CompletionMar 1, 2005
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.8 years ago

Interventions

MEDI-528 0.3 mg/kgbiological

MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose

MEDI-528 1 mg/kgbiological

MEDI-528 (1 mg/kg) administered as a single, IV dose

MEDI-528 3 mg/kgbiological

MEDI-528 (3 mg/kg) administered as a single, IV dose

MEDI-528 9 mg/kgbiological

MEDI-528 (9 mg/kg) administered as a single, IV dose