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

Korábbi kezelés

• 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.
• Regular use (more than 2 visits per week) of a tanning booth/parlor or extended sun exposure (per investigator judgement) within 4 weeks prior to baseline visit

Más betegség

• Evidence of active or latent TB infection, as determined by T-Spot test during screening period.
• History of immunodeficiency diseases, or a positive human immunodeficiency virus (HIV) test result.
• Recent (within last half year) or ongoing helminth infection.
• History of hepatitis B or hepatitis C or serologic evidence for viral hepatitis. A positive Hepatitis B virus surface antigen (HBsAg), Hepatitis B virus core antibody (HBcAb) and/or Hepatitis B surface antibody (HBsAb) test during screening period excludes a participant. A positive test for HBsAb can be included if the test for HBsAg and HBcAb are negative and the history of hepatitis B vaccination is known. Participants with a positive Hepatitis C virus (HCV) antibody test should be excluded.
  • Healthy Participants (Part 1)
• Have any chronic, uncontrolled medical condition, which would put the participant at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, cardiovascular, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per investigator judgment
• Women of childbearing potential (WOCBP) are excluded unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 202 days (= 5 times the terminal half-life) of study treatment after stopping study treatment.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Egyéb

• All Participants (Part 1, Part 2)
• A positive syphilis test result during screening period.
• Women of childbearing potential
• Smokers Participants with moderate to severe atopic dermatitis (Part 2)

• 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
  • IGA score ≥3 at screening visit and baseline visit
  • Total Body surface area (BSA) affected by AD ≥ 10 % at screening visit and baseline visit
  • Peak Pruritus NRS score ≥4 at baseline visit, based on weekly average of daily assessment in the week prior to baseline visit