A Phase 1 interventional study of MEDI-563 in Asthma, sponsored by MedImmune LLC. Completed at 3 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-11-27.
Sponsored by MedImmune LLC · Phase 1 and Interventional
The primary objective of this study is to investigate the safety of administration of this drug by increasing doses to male and female adult subjects with mild asthma.
The primary objective of this study is to investigate the safety of administration of BIW-8405/MEDI-563 in increasing doses to male and female adult subjects with mild asthma.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's planned enrollment of 42 is below the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MEDI-563
Biological: MEDI-563
BIW-8405/MEDI-563 administered at one of five dose levels: * 0.03 mg/kg intravenous injection * 0.1 mg/kg intravenous injection * 0.3 mg/kg intravenous injection * 1.0 mg/kg intravenous injection * 3.0 mg/kg intravenous injection Following the -3.0 mg/kg dose level, BIW-8405/MEDI-563 administered at one of two lower dose levels: 0.003 mg/kg intravenous injection 0.0003 mg/kg intravenous injection
The primary endpoint will be the overall incidence of adverse events reported in each dose group.
Time frame: Day 84
Laboratory assessments of safety (hematology, biochemistry and urinalysis), assessments of immunogenicity, vital signs, physical examinations, and ECGs.
Time frame: Day 84
Safety will also be assessed by measurement of T-cell, B-cell, and NK counts using fluorescence activated cell sorter (FACS) technology.
Time frame: Day 84
Secondary pharmacological endpoints will include assessments of eosinophil counts in peripheral blood, FENO, and ECP.
Time frame: Day 84
This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
MedImmune LLC