This study will investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RLYB116 (with an improved impurity profile) following repeated administration of RLYB116 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
RLYB116 is a small protein composed of an Affibody® Z-domain that binds with high affinity to C5, inhibiting terminal complement activation, and an albumin binding domain (ABD) that extends the effective plasma half-life of the protein by targeting serum albumin.
Nucleus Network Brisbane
Brisbane, Queensland, Australia
Number of participants with treatment related adverse events as defined by CTCAE 5.0.
Time frame: From baseline to Day 1, 2, 3, 4, 5, 8, 9, 15, 16, 22, 23, 29, 30, 32, 33, 36, 43, 57, 71, 99
Inhibition of complement activation measured by free/total C5 concentrations and hemolytic activity
Time frame: Day 1, 2, 8, 15, 29, 20, 32, 33, 43, 57, 71, 99
Anti-RLYB116 antibodies measured in serum
Time frame: Day 1, 29, 99
Exposure to RLYB116 as measured in serum
Time frame: Day 1, 2, 3, 4, 5, 8, 15, 29, 53, 57, 71, 99
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