Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing DCY636 for Dermatitis, Atopic

The purpose of this first-in-human (FIH) study is to assess the whether it is safe and how hard side effects are to live with, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636. The results are intended to support the further clinical development of DCY636 in future studies.

Official registry: https://clinicaltrials.gov/study/NCT07604324 · Novartis Pharmaceuticals · enrollment listed as 63

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are DCY636, or Placebo. The registry lists allocation as randomized. The purpose of this first-in-human (FIH) study is to assess the whether it is safe and how hard side effects are to live with, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636.

They plan to enroll about 63 people at Fukuoka. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Two-part, Randomized, Participant- and Investigator-blinded, Placebo Controlled First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of DCY636 in a Single Ascending Dose Part in Healthy Participants and in a Multiple Dose Part in Participants With Moderate to Severe Atopic Dermatitis

Interventions: DCY636, Placebo

Primary outcome (registry wording): Part 1-Incidence of adverse events (AEs) and serious adverse events (SAEs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 55 Years
  • Healthy Participants (Part 1)
  • Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive
  • Participants with moderate to severe atopic dermatitis (Part 2)
  • Males and non-pregnant females age 18 years or older
  • Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topicals
  • Moderate to severe atopic dermatitis as defined by all of the following:
  • EASI score ≥12 at screening visit and ≥16 at baseline (BL) visit

Public study contact (from the registry)

Novartis Pharmaceuticals

+81337978748

novartis.email@novartis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Studies of Skin Microbes in Healthy People and in People With Skin Conditions

This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.

NCT00605878 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

FAQ about this NCT record

Is NCT07604324 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07604324?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07604324?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary