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:

For healthy volunteers:

• Men and women between 18 and 55 years old at the time of the screening visit
• People with a body mass index (BMI) between 18.5 and 28, and a body weight of at least 50 kg for men or at least 45 kg for women
• People who are willing to take part voluntarily and sign a consent form
• Women who cannot become pregnant (due to surgical sterilization or menopause for at least 12 months, confirmed by a hormone blood test), OR women who could become pregnant but are not currently pregnant or breastfeeding, have used non-hormonal contraception for at least 30 days before the study and agree to continue for 3 months after dosing, and have tested negative for pregnancy at screening and before the first dose — and who agree not to donate eggs during this period
• Men who are sexually active with women who could become pregnant must have used non-hormonal contraception from 14 days before dosing, throughout the study, and for 3 months after dosing — and must agree not to donate sperm during this period
• People who are willing to follow all study procedures, attend all required visits, and complete required tests

For people with plaque psoriasis:

• Men and women between 18 and 70 years old at the time of the screening visit
• People with a BMI between 18 and 35, and a body weight of at least 40 kg
• People who have been diagnosed with plaque psoriasis for at least 6 months before the first dose, whose psoriasis has been stable without major changes, has a PASI score of 12 or higher (a measure of psoriasis severity), a physician's global assessment score of 3 or higher, and plaques covering at least 10% of the body surface area (confirm with trial site for scoring details)
• People whose doctor considers them suitable for light therapy or systemic (whole-body) treatment for psoriasis
• People who are willing to stop other topical or systemic psoriasis treatments during the study, except for moisturisers and low-strength topical steroids used for temporary relief
• People who are willing to take part voluntarily and sign a consent form
• Women and men meeting the same contraception and pregnancy-related requirements as described above for healthy volunteers
• People who are willing to follow all study procedures, attend all required visits, and complete required tests

Who may not be able to join:

For healthy volunteers:

• People who are allergic to the study drug or its ingredients, or who have a history of severe allergies, including food or drug allergies
• People who have previously received a type of medicine called an IL-17 small molecule inhibitor
• People with a personal or family history of psychiatric disorders or inherited immune system problems
• People who have had a stem cell transplant or organ transplant at any point in the past
• People with a history of long-term or repeated infections, or infections caused by fungi, parasites, or certain other organisms
• People with a history of active or latent (inactive) tuberculosis (TB), inadequately treated latent TB, or who have been in close contact with someone who has TB
• People who have had a serious bone or joint infection in the 6 months before screening, a serious infection requiring hospitalisation or intravenous antibiotics, or a shingles (herpes zoster) infection in the 3 months before screening
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People who currently have any active infection or symptoms of infection
• People with unhealed surgical wounds, unhealed fractures, serious mouth or gut ulcers, or a risk of gastrointestinal bleeding or perforation (such as active stomach ulcers, bowel blockage, ulcerative colitis, or gastrointestinal perforation in the 6 months before screening)
• People with abnormal liver function test results in the 3 months before dosing, or clinically significant abnormal liver results found during screening
• People with clinically significant abnormal blood clotting results
• People with a known or suspected history of drug abuse, or who test positive for drug use at screening
• People who have drunk more than 14 standard units of alcohol per week in the year before screening, or who have a positive breath alcohol test at screening
• People who smoke more than 5 cigarettes per day (or the equivalent in other nicotine products) in the 3 months before screening, or who cannot follow the study's no-smoking rules
• People who have received any vaccine in the 3 months before screening, or who plan to have a vaccine during the study
• People who have taken part in another clinical trial or received an experimental drug in the 3 months before dosing
• People who have had surgery in the 3 months before screening, or who plan to have surgery during the study
• People with a significant current or past serious illness affecting the brain, heart, liver, kidneys, lungs, digestive system, blood, bones, or immune system
• People with a history of abdominal surgery that has changed the structure or function of the digestive tract
• People with structural abnormalities of the digestive tract, a history of conditions such as gastrointestinal bleeding, perforation, reflux disease, inflammatory bowel disease, gallstones, or current symptoms such as nausea, vomiting, or diarrhoea
• People who have had unexplained diarrhoea within the 3 months before screening
• People with clinically significant abnormal results in vital signs, physical examination, or required lab tests
• People with a clinically significant abnormal heart tracing (ECG), including a QTcF interval above 450 ms for men or 470 ms for women (a measure of heart rhythm timing)
• People whose kidney filtration rate (creatinine clearance) is below 90 mL/min as calculated by the Cockcroft-Gault formula
• People who have taken certain medications that interact with the study drug (such as CYP3A4 inhibitors or inducers, or P-gp inhibitors) in the 7 days before dosing (confirm with trial site for the full list)
• People who have taken medications that affect how the liver processes drugs in the 7 days before screening, or who have eaten foods such as grapefruit that affect liver enzymes in the 48 hours before dosing, or who cannot avoid caffeine- or xanthine-containing food and drinks (such as coffee, tea, or chocolate) from 48 hours before the first dose until the last blood sample
• People who cannot avoid taking non-approved medications — including prescription drugs, over-the-counter medicines, non-standard vitamins, supplements, or herbal medicines — from 14 days (or 5 half-lives, whichever is longer) before dosing until the last visit
• People who have donated or lost 400 mL or more of blood in the 3 months before screening, or who plan to donate blood during the study
• People who are unable to have blood drawn through a needle, or who have a history of fainting at the sight of blood or needles

For people with plaque psoriasis:

• People who are allergic to the study drug or its ingredients, or who have a history of severe allergies, including food or drug allergies
• People who have previously received an IL-17 small molecule inhibitor
• People diagnosed with a non-plaque form of psoriasis (such as guttate, inverse, pustular, or erythrodermic psoriasis)
• People whose psoriasis is known or suspected to be caused or worsened by certain medications, including beta-blockers, calcium channel blockers, or lithium
• People who have or are suspected to have another skin or autoimmune disease in addition to psoriasis or psoriatic arthritis
• People who did not respond to certain biologic treatments for psoriasis (including ustekinumab, guselkumab, tildrakizumab, secukinumab, ixekizumab, or brodalumab) after at least 3 months of treatment at the approved dose
• People who have received any of those same biologic treatments within 3 months before the first dose of the study drug
• People who have received TNF-alpha inhibitors (such as etanercept, infliximab, adalimumab, or sacituzumab) within 2 months before the first dose
• People who have received phototherapy or systemic psoriasis treatments (including certain oral medicines and herbal treatments) within 1 month before the first dose
• People who have used topical psoriasis treatments (such as steroid creams, vitamin D creams, or certain other skin preparations) within 2 weeks before the first dose
• People who have received certain other monoclonal antibody treatments (such as natalizumab, efalizumab, alemtuzumab, abatacept, alefacept, or visilizumab) within 3 months, or rituximab within 6 months, before the first dose
• People with a personal or family history of psychiatric disorders or inherited immune system problems
• People who have had a stem cell transplant or organ transplant at any point in the past
• People with a history of long-term or repeated infections, or infections caused by fungi, parasites, or certain other organisms
• People with a history of active or latent (inactive) tuberculosis (TB), inadequately treated latent TB, or who have been in close contact with someone who has TB
• People who have had a serious bone or joint infection in the 6 months before screening, a serious infection requiring hospitalisation or intravenous antibiotics, or a shingles (herpes zoster) infection in the 3 months before screening
• People who test positive for hepatitis B, hepatitis C, HIV, or syphilis
• People who currently have any active infection or symptoms of infection
• People with unhealed surgical wounds, unhealed fractures, serious mouth or gut ulcers, or a risk of gastrointestinal bleeding or perforation
• People who have been diagnosed with a malignant tumour or blood cancer in the past 5 years, with the exception of certain treated skin cancers or cervical carcinoma in situ with no recurrence in the past 3 years
• People with severe heart failure (Class III or IV by standard medical classification), or unstable heart disease including a significant deterioration or hospitalisation for heart problems in the last 3 months
• People with clinically significant abnormal white blood cell, lymphocyte, or neutrophil counts below the normal range
• People with abnormal liver function test results in the 3 months before dosing, or clinically significant abnormal liver results found during screening
• People whose kidney filtration rate (creatinine clearance) is below 60 mL/min as calculated by the Cockcroft-Gault formula
• People with clinically significant abnormal blood clotting results
• People with a known or suspected history of drug abuse, or who test positive for drug use at screening
• People who have drunk more than 14 standard units of alcohol per week in the year before screening, or who have a positive breath alcohol test at screening
• People who smoke more than 5 cigarettes per day (or the equivalent in other nicotine products) in the 3 months before screening, or who cannot follow the study's no-smoking rules
• People who have received any vaccine in the 3 months before screening, or who plan to have a vaccine during the study
• People who have received an experimental biologic or antibody therapy in the 6 months before dosing, or any other experimental therapy within 30 days or 5 half-lives (whichever is longer) before dosing
• People who have had surgery in the 3 months before screening, or who plan to have surgery during the study
• People who have donated or lost 400 mL or more of blood in the 3 months before screening, or who plan to donate blood during the study
• People who are unable to have blood drawn through a needle, or who have a history of fainting at the sight of blood or needles
• People with any other serious illness, significant abnormal test results, or other concerns that the investigator considers to make participation unsafe

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