A First in Human Study of STT-5058, an Antibody That Binds ApoC3, investigating single and multiple ascending intravenous doses and ascending subcutaneous doses of STT-5058 in otherwise healthy volunteers with elevated triglyceride levels
The study is in five parts. Part A is up to 6 single ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs \>150mg/dL. Part B is up to 4 multiple ascending intravenous dose cohorts of STT-5058 in otherwise healthy volunteers with TRGs \>150mg/dL who will receive 3 doses at 2 week intervals. Part C will recruit a single cohort of patient volunteers with TRG \>200mg/dL who will receive 3 doses at 2 week intervals of STT-5058. Part D will investigate up to 2 single ascending doses of subcutaneous STT-5058. Part E will recruit a single cohort of otherwise healthy volunteers with TRG \> 150mg/dL to receive 4 doses subcutaneously of STT-5058 over 4 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
93
Covance Leeds Clinical Research Unit
Leeds, West Yorkshire, United Kingdom
Safety and tolerability
incidence and severity of adverse events
Time frame: 10 weeks
AUC
Area under the PK curve
Time frame: 10-14 weeks
Cmax
Maximum concentration
Time frame: 24 hours
Half life
time to reduction in plasma levels by 50%
Time frame: 10-14 weeks
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