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 aged 18 to 70 years old at the time of signing the consent form
• People who weigh at least 50 kg and have a body mass index (BMI) between 18.5 and 35.0
• People who are in good general health, as assessed by the study doctor based on medical history, physical examination, and lab tests
• For the healthy participant groups only: people with no significant abnormalities found on a heart tracing (ECG) test at screening
• For the skin condition group (Phase 1b) only: people with a confirmed diagnosis of atopic dermatitis (a type of eczema) where symptoms started at least one year before the screening visit
• For the skin condition group (Phase 1b) only: people whose atopic dermatitis is rated as moderate-to-severe at both the screening visit and the first dosing visit
• People who are not pregnant and not breastfeeding, and who have a negative pregnancy test at screening and before the first dose
• For the healthy participant groups only: people who do not smoke, or who smoke no more than 5 cigarettes per week and have done so for the past 6 months
• People who agree not to use any products containing THC (the active substance in cannabis) during the study

Who may not be able to join:

• People with a history of any significant illness or medical condition that, in the study doctor's opinion, could put them at risk or affect the study results
• People who have needed medicines that suppress or modify the immune system within a defined period before screening (confirm with trial site for exact timeframe)
• People who have used a biologic medicine — such as a monoclonal antibody — within 3 months or 5 half-lives of the drug (whichever is longer) before the first dosing day
• People who have taken part in another clinical drug trial within 30 days or 5 half-lives of the previous trial drug (whichever is longer) before the first dosing day
• People with a known allergy or sensitivity to any ingredient in the study drug or the placebo
• People with a known active or latent tuberculosis (TB) infection, or a history of TB treatment that was not completed
• People who test positive at screening for hepatitis B, hepatitis C, or HIV
• People with a current active infection, or who have had a serious infection within 4 weeks before the first dosing day
• People with significant heart tracing (ECG) abnormalities or other cardiac risk factors (for example, a specific heart rhythm measurement that is too high)
• People with abnormal and clinically significant blood or urine test results at screening
• People who have received a live vaccine within 4 weeks before the first dosing day
• For the skin condition group only: people who have used steroid tablets or capsules, immune-suppressing medicines, or immune-modifying medicines within certain washout periods before the study (confirm with trial site for exact timeframes)
• People with a recent history of alcohol or drug misuse, as defined by the study protocol (confirm with trial site for exact definition)
• For the healthy participant groups only: people whose tobacco or nicotine use is beyond the limits allowed by the study protocol
• For the healthy participant groups only: people who test positive for cotinine (a marker of nicotine use) at the check-in visit
• People who have had surgery in the 90 days before dosing that the study doctor considers clinically relevant, or who have surgery planned during the study or within 30 days after the last dose
• People with any medical or psychiatric condition that, in the study doctor's or sponsor's opinion, could put them at risk, affect their ability to take part, or make the results harder to interpret
• People who, for any other reason, are considered by the study doctor or sponsor to be unsuitable for the trial

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