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.
Males and non-pregnant females age 18 years or older
Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topicals
EASI score ≥12 at screening visit and ≥16 at baseline (BL) visit
IGA score ≥3 at screening visit and baseline visit
Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer.
Meet any of the prohibited medication use criteria at baseline visit.
A positive syphilis test result during screening period.
Evidence of active or latent TB infection, as determined by T-Spot test during screening period.
Parallel
DCY636
DrugParticipants will receive DCY636
Placebo
DrugParticipants will receive Placebo
14
Treatment groupsSee each treatment group below.
Part 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.
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.
Part 1-Pharmacokinetic (PK) parameter: Cmax of DCY636
Cmax is the maximum (peak) observed blood concentration of DCY636 after dose administration.
Part 1-Pharmacokinetic (PK) parameter: AUC of DCY636
AUC is the area under the plasma concentration-time curve.
Part 1-Anti-drug antibodies against DCY636
To assess immunogenicity (IG) of DCY636.
Part 2-Pharmacokinetic (PK) parameter: Cmax of DCY636
Cmax is the maximum (peak) observed blood concentration of DCY636 after dose administration.
Click on the lead sponsor to view all of their trials.
