CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
MEDI-528 0.3 mg/kg +3 morebiological
Likely dose
MEDI-528 0.3 mg/kg, 1 mg/kg, 3 mg/kg, or 9 mg/kg as a single subcutaneous doseAI-extracted
Key inclusion· 5
  • ✓Age 19 to 49 years at first dose
  • ✓Body weight less than 89 kg
  • ✓Healthy by medical history and physical examination
  • ✓Ability to complete 84-day follow-up period
Key exclusion· 10
  • ✕Acute illness or significant active infection (fever ≥38.0°C)
  • ✕Use of prescription medications (except oral contraceptives) within 28 days before study
  • ✕Blood donation or significant blood loss within 6 months
  • ✕History of immunodeficiency or immunosuppressive drug use

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

Search/NCT00116168
NCT00116168Phase 1Completed
CompareCT.gov

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

MedImmune LLC·interventional·Posted Jun 28, 2005·Updated Dec 11, 2013

In Brief

A Phase 1 clinical trial evaluating MEDI-528 0.3 mg/kg, MEDI-528 1 mg/kg, and 2 other interventions for Healthy. Completed, enrolled 29 participants across 2 sites.

Detailed Summary

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

Study Details

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

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2005
Enrollment StartJun 1, 2005
Primary CompletionApr 1, 2006
Study CompletionJul 1, 2006
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 21.0 years ago

Interventions

MEDI-528 0.3 mg/kgbiological

MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose

MEDI-528 1 mg/kgbiological

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

MEDI-528 3 mg/kgbiological

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

MEDI-528 9 mg/kgbiological

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