First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis

Korábbi kezelés

• Hospitalized (>24 hours) for any reason within 30 days prior to the screening visit
• Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study
• Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list

Más betegség

• Hypersensitivity to the study treatment or any of its excipients
• History of clinical parasite infection, except treated trichomoniasis
• History of alcohol or drug abuse as determined by the investigator
  • Part B:
• Known or suspected history of immunosuppression
• Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study
  • Note: Other protocol defined Inclusion/ Exclusion criteria apply

Egyéb

• Part A:
• Presence of skin comorbidities at screening that may interfere with study assessments

• Part A:
• Maximum age of 65 years of age (Part A Only)
• Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention
• Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit
  • Part B:
• Has a history of AD for at least 6 months at screening
• Has EASI score ≥5 at both the screening and baseline visits
• Has IGA score ≥2 at both the screening and baseline visits

A regiszterben nem jelölt feltételek

• Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis