A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic Brain Injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
57
Site Reference ID/Investigator# 45771
Baltimore, Maryland, United States
Site Reference ID/Investigator# 45775
Dayton, Ohio, United States
Site Reference ID/Investigator# 45770
Portland, Oregon, United States
Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG
Time frame: 2 weeks
PK parameters of SLV334
Time frame: up to 4 days
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2000mg SLV334 b.i.d. for three days
SLV334 Placebo arm
Site Reference ID/Investigator# 45785
Pittsburgh, Pennsylvania, United States
Site Reference ID/Investigator# 45780
Pittsburgh, Pennsylvania, United States
Site Reference ID/Investigator# 45727
Haifa, Israel
Site Reference ID/Investigator# 45726
Jerusalem, Israel
Site Reference ID/Investigator# 45723
Ramat Gan, Israel
Site Reference ID/Investigator# 45725
Tel Aviv, Israel
Site Reference ID/Investigator# 45735
Milan, Italy
...and 4 more locations