This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when administered to healthy volunteers (HVs). The study in HVs will be a randomized, double blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) (Part B) study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment
Time frame: SAD Part A- 28 days. MAD Part B - 57 days
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