This is a randomized, double-blind, placebo-controlled, single ascending dose trial evaluating the safety, tolerability, PK, and immunogenicity of STAR-0310 in healthy adult participants. There are 4 planned cohorts and potentially up to 1 additional cohort which may comprise of healthy adult participants of Japanese descent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Austin Clinical Research Unit - Early Clinical Development
Austin, Texas, United States
Number of Participants Experiencing Treatment-emergent Adverse Events
Time frame: [Time Frame: Day 1 through Day 252]
Serum Concentration of STAR-0310
Blood samples will be collected to measure the serum concentration of STAR-0310 before and after study drug administration.
Time frame: [Time Frame: Day 1 (predose up to 2 hours before study drug administration, and 12 hours post dose), Days 2, 3, 7, 10, 14, 21, 28, 42, 56, 84, 112, 140, 168, 196, 224, 252 ]
Number of Participants with Anti-drug Antibodies to STAR-0310
Blood samples will be collected to assess the formation of STAR-0310 anti-drug antibodies in serum before and after study drug administration.
Time frame: [Time Frame: Day 1 predose, Days 14, 28, 84, 168, 252 ]
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