The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Investigational Product
0.9% normal saline SC injection
Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia
RECRUITINGNucleus Network Pty Ltd.
Melbourne, Victoria, Australia
RECRUITINGin SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681
Incidence, severity, and causal relationship of adverse events (AEs) as reported by the Investigator, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0
Time frame: From the enrollment to the end of treatment at Day180
in POC cohort, To assess the metabolic markers of efficacy
Percent change from Baseline in serum LDL-C and Lp(a) at Day 180
Time frame: From enrollment to the end of treatment at Day 180
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