This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
CLYM116 is a humanized monoclonal antibody that selectively binds to a proliferation inducing ligand (APRIL). This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of CLYM116 in adult normal healthy volunteers (NHVs). The study will enroll up to 48 subjects, across up to five cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
48
Nucleus Network Brisbane
Brisbane, Australia
RECRUITINGSafety and tolerability of single and multiple ascending doses of CLYM116 in healthy volunteers Incidence of treatment-emergent adverse events
Time frame: From Screening through to Day 85, or final follow-up visit
Incidence of injection site reactions Number of injection site reactions
Time frame: From Baseline through to Day 4 and Day 15 to Day 18
Maximum Observed Plasma Concentration (Cmax) Measurement of the maximum observed plasma concentration.
Time frame: From Baseline through to Day 85 (except Day 14), or final follow-up visit
Time to Maximum Observed Concentration (Tmax) Measurement of the time to maximum observed concentration.
Time frame: From Baseline through to Day 85 (except Day 14), or final follow-up visit
Area Under the Curve (AUC) Measurement of the area under the drug concentration-time curve.
Time frame: From Baseline through to Day 85 (except Day 14), or final follow-up visit.
Half-Life (T1/2) Measurement of the half-life in days
Time frame: From Baseline through to Day 85 (except Day 14), or final follow-up visit
Levels of Immunoglobulins Measurement of Immunoglobulins and changes over time
Time frame: From Screening through to Day 85, or final follow-up visit
Level of APRIL Measurement of APRIL in pg/mL and changes over time
Time frame: Day -1, Baseline, Day 1, Day 4, Day 8, Day 14, Day 15, Day 17, Day 18, Day 22, Day 29, Day 71, day 85, final follow up visit
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Immunogenicity Measurement of CLYM116 antidrug antibodies (ADA)
Time frame: Baseline, Day 15, Day 29, Day 43, Day 71, Day 85, follow-up visit