Phase 1 Eczema Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to understand and sign a consent form agreeing to take part
• Healthy men and women aged 18 to 55 years old (inclusive) at the screening visit, with suitable veins for blood draws or needle insertion
• People whose body weight and body mass index (a measure of body size based on height and weight) falls within the range of 18.5–29.9, with a body weight of at least 50 kg and under 95 kg at screening
• People who are available for the full length of the study
• Female participants must have a negative pregnancy blood test at both the screening visit and on the day before dosing begins
• Female participants must not be pregnant, breastfeeding, or nursing, and must meet at least one additional condition related to childbearing status (confirm with trial site)
• Male participants and their female partners who could become pregnant must use two forms of contraception from screening until at least 3 months after the last dose of the study treatment

Who may not be able to join:

• People with a history of any significant illness or medical condition that could put them at risk during the study
• People who have had an important medical or surgical procedure or injury within 8 weeks before screening, or who have a planned hospital stay during the study
• People who have previously been given dupilumab (also known as Dupixent or a similar medicine)
• People who have taken part in another clinical trial or received an experimental medicine within 30 days (or fewer than 5 half-lives of that medicine) before the dosing date
• People who have had cancer in the past 5 years, currently have cancer, or have a suspected or unidentified growth or tumour
• People with a history of ongoing or long-term disease affecting the digestive system, liver, kidneys, or pancreas, or any active disease in these organs, or any other condition that could make taking the study medicine risky
• People who have a diagnosed or historical immune system deficiency, a high vulnerability to serious infections, or a significant infection within 4 weeks before screening
• People whose blood, urine, or chemistry test results show abnormal findings at screening or on admission, as assessed by the study doctor
• People whose white blood cell count is below the normal range at screening or on admission
• People with significantly abnormal vital signs (such as blood pressure or heart rate), as assessed by the study doctor
• People with significantly abnormal heart trace (ECG) results at screening or on the day before dosing, as assessed by the study doctor
• People who test positive for drugs of abuse or alcohol at screening or on admission to the clinic
• People with a known or suspected history of alcohol or drug misuse, or heavy alcohol use within 1 year before screening, as assessed by the study doctor
• People who smoke more than 5 cigarettes per day or use an equivalent amount of nicotine products (including e-cigarettes), or who are unable to avoid smoking during the in-clinic stay
• People who have received a live or live-attenuated vaccine within 1 month before screening, or who plan to receive one during the study
• People who have a known parasitic worm (helminth) infection, or have had one within 6 months before screening
• People who test positive for HIV, Hepatitis B, or Hepatitis C at screening (except those who have been vaccinated or had a fully resolved past hepatitis infection)
• People who are unwilling to avoid coffee and caffeine-containing drinks within 48 hours before admission or before any outpatient visits
• People who regularly consume more than 500 mg of caffeine per day (roughly more than 5 cups of coffee) within 14 days before the study medicine is given
• People who have donated more than 500 mL of blood or blood products within 56 days before admission
• People who have used over-the-counter medicines (including vitamins), prescription medicines, or herbal remedies from 14 days before admission through to the end of the study
• People with a history of severe allergic reactions, significant ongoing allergies, a history of allergic reactions to antibody-based medicines, or an allergy to any ingredient in the study medicine
• People who are unable to understand the study requirements, instructions, or what taking part involves
• People who are unlikely to follow the study requirements and instructions
• People who have already been enrolled in this trial before
• People who are in a vulnerable situation, such as being held in detention, under legal guardianship, or placed in an institution by a government or court order
• Employees of the sponsoring company (Chong Kun Dang Pharmaceutical), the research organisation (Parexel), or the study site, or their close family members

Important: Always verify eligibility with the trial site directly before applying.