This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Each cohort will receive one single dose of Sym001 according the assigned dose level.
Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs)
Time frame: 6 weeks post dosing
Measurements of platelet counts
Time frame: From day 1 through week 6
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Univ Nebraska Med Ctr. UNMC, 1005
Omaha, Nebraska, United States
Hospital of the University of Pennsylvania, Site 1002
Philadelphia, Pennsylvania, United States
2085 Henry Tecklenburg Drive, 1001
Charleston, South Carolina, United States
Research Site 3203
Bruges, Belgium
Research Site 3202
Leuven, Belgium
Research Site 3201
Yvoir, Belgium
Research Site 4906, 4907
Berlin, Germany
Research Site 4902
Cologne, Germany
Research Site 4903
Duisburg, Germany
Research Site 4905
Essen, Germany
...and 49 more locations