A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple Doses in Participants With Moderate to Severe Atopic Dermatitis

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • DCY636
  • Placebo

Treatment groups

63 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Sponsors and collaborators