This is a double-blind, randomized, placebo-controlled, single ascending dose (SAD) study to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of DF5112 in healthy adult participants. A total of 64 participants are planned to be randomized into 8 cohorts. Additional cohorts at intermediate dose levels may be evaluated. Each cohort will include 8 healthy participants randomized to receive DF5112 or placebo through intravenous (IV) or subcutaneous (SC) administration. Following dose administration participants will be confined at the clinical research unit for observation for approximately 1 week and then will return for subsequent pre-identified follow up visits through at least Day 29, Day 57, or Day 85 (length of follow-up is determined by the cohort).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
64
Scientia Clinical Research Ltd
Sydney, New South Wales, Australia
Number of participants with Treatment Emergent Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From Day 1 dosing to end of study at Day 29, 57, or 85 (depending on cohort)
To evaluate the PK of single ascending doses of DF5112 administered by IV or SC injection
PK parameter: Area Under the Concentration Curve (AUC)
Time frame: From Day 1 dosing to end of study at Day 29, 57, or 85 (depending on cohort)
Incidence and titer of Anti-Drug Antibodies
Time frame: From Day 1 dosing to end of study at Day 29, 57, or 85 (depending on cohort)
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