This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
STAR-0215 will be administered as an SC bolus injection.
Placebo will be administered as an SC bolus injection.
STAR-0215 will be administered as an IV bolus injection.
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Day 224
Serum Concentration of STAR-0215
Blood samples will be collected to measure the serum concentration of STAR-0215 before and after study drug administration.
Time frame: Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224
Plasma Levels of Cleaved High-molecular-weight Kininogen
Blood samples will be collected to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity).
Time frame: Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224
Number of Participants with Anti-drug Antibodies to STAR-0215
Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration.
Time frame: Day 1 (pre-dose, up to 2 hours before study drug administration); Days 28, 56, 84, 112, 140, 168, 196, and 224
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Placebo will be administered as an IV bolus injection.