A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

May 31, 2010

Study Completion Date

July 31, 2011

Conditions
Scleroderma
Interventions
DRUG

MEDI-546

0.1 mg/kg MEDI-546 as a single IV dose

DRUG

MEDI-546

0.3 mg/kg MEDI-546 as a single IV dose

DRUG

MEDI-546

1.0 mg/kg MEDI-546 as a single IV dose

DRUG

MEDI-546

3.0 mg/kg MEDI-546 as a single IV dose

DRUG

MEDI-546

10.0 mg/kg MEDI-546 as a single IV dose

DRUG

MEDI-546

0.3 mg/kg MEDI-546 as a weekly IV dose x 4 doses

DRUG

MEDI-546

1.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses

DRUG

MEDI-546

5.0 mg/kg MEDI-546 as a weekly IV dose x 4 doses

DRUG

MEDI-546

20.0 mg/kg MEDI-546 as a single IV dose

Trial Locations (11)

11042

Research Site, Lake Success

43614

Research Site, Toledo

48106

Research Site, Ann Arbor

75231

Metroplex Clinical Research Center, Dallas

77030

Research Site, Houston

84132

University of Utah Medical Center, Salt Lake City

90095

Research Site, Los Angeles

98101

Research Site, Seattle

02118

Boston University, Boston

08903

Research Site, New Brunswick

Unknown

Research Site, Salt Lake City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY

NCT00930683 - A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma | Biotech Hunter | Biotech Hunter