The purpose of this first-in-human (FIH) study is to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636. The results are intended to support the further clinical development of DCY636 in future studies.
This is a two-part FIH, randomized, placebo-controlled, participant- and investigator-blinded study in healthy participants (Part 1) and participants with moderate to severe AD (Part 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
Novartis Investigative Site
Fukuoka, Japan
RECRUITINGPart 1-Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Time frame: Up to approximately 202 days
Part 2-Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Time frame: Up to approximately 301 days
Part 1-Pharmacokinetic (PK) parameter: Cmax of DCY636
Cmax is the maximum (peak) observed blood concentration of DCY636 after dose administration.
Time frame: up to Day 202
Part 1-Pharmacokinetic (PK) parameter: AUC of DCY636
AUC is the area under the plasma concentration-time curve.
Time frame: up to Day 202
Part 1-Anti-drug antibodies against DCY636
To assess immunogenicity (IG) of DCY636.
Time frame: up to Day 202
Part 2-Pharmacokinetic (PK) parameter: Cmax of DCY636
Cmax is the maximum (peak) observed blood concentration of DCY636 after dose administration.
Time frame: up to Day 301
Part 2-Pharmacokinetic (PK) parameter: AUC of DCY636
AUC is the area under the plasma concentration-time curve.
Novartis Pharmaceuticals
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Time frame: up to Day 301
Part 2-Anti-drug antibodies against DCY636
To assess immunogenicity (IG) of DCY636.
Time frame: up to Day 301