Phase 1 Psoriasis 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 give signed consent and follow the study rules as outlined in the study documents
• Healthy men or women aged 18 to 55 years (inclusive) at the time of signing the consent form
• People who smoke 10 or fewer cigarettes per week within the 3 months before the screening visit
• People who can avoid alcohol for 48 hours before receiving the study treatment, and who generally keep alcohol consumption within World Health Organization limits (no more than 14 units per week, spread across 3 or more days — roughly equivalent to 6 pints of average-strength beer or 6 medium glasses of wine)
• People who have suitable veins for blood draws
• Women who are neither pregnant nor breastfeeding at the time of participation
• Men who agree not to donate sperm from the time of signing the consent form until at least 30 days after the final study visit
• People who are willing to use effective or highly effective contraception throughout the study period
• People who are willing and able to stay at the clinical unit before and during the study treatment and any required follow-up periods

Who may not be able to join:

• People who have previously been treated with any anti-IL-12/23 or anti-IL-23 therapy (a specific type of medication) (confirm with trial site)
• People with a history of significant drug or food allergies
• People with a history of allergic reaction to Skyrizi (risankizumab) or any of its ingredients
• People with a psychiatric condition or altered mental state that would prevent them from understanding the consent process or completing the study procedures
• People whose medical history, physical examination, or laboratory test results show a significant health condition that, in the investigator's opinion, could put them at risk
• People who have had major surgery within the 12 weeks before being enrolled in the study
• People with a known or suspected active cancer, or a history of cancer within the 5 years before the screening visit
• People who test positive for hepatitis B, hepatitis C, or HIV (types 1 or 2) at screening
• People who test positive for COVID-19 on admission to the study unit (note: this test is listed as optional)
• People with a current active infection, or who have had an active infection within the week before receiving the study treatment
• People with a history of tuberculosis (TB), or evidence of active or latent TB infection
• People with abnormal liver, kidney, or blood test results at screening (the investigator may allow one repeat test before making a final decision)
• People with any other laboratory result outside the normal range that the investigator considers clinically significant
• People with abnormal vital signs, including: blood pressure outside the range of 90–140 mmHg (systolic) or 50–90 mmHg (diastolic), or a resting heart rate below 45 or above 100 beats per minute
• People with clinically significant abnormalities on a resting ECG (heart tracing)
• People with any past or current medical conditions, or active infection, that could increase risk or interfere with the study
• People who have taken any prescription or non-prescription medicines or vitamins within 7 days (or 5 half-lives, whichever is longer) before admission, unless the investigator determines this would not affect safety or study results
• Men or women who are currently participating in another clinical trial at the time of consenting
• People who have received any investigational (experimental) drug within 30 days before screening, or within 5 half-lives of that drug — whichever period is longer
• People who have received a live vaccine in the 4 weeks before screening, or who plan to receive any vaccination during the 21-week treatment and assessment period
• People who have donated more than 500 mL of blood or blood products within the 2 months (56 days) before screening
• People with a history of drug or alcohol abuse, as determined by the investigator
• People who work at the trial site or for the study sponsor, or who may feel pressured into consenting
• People who are unlikely to cooperate with the study requirements

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