Immune-mediated and inflammatory disorders with initial indications in psoriasis, psoriatic arthritis, and Crohn’s disease. Other
Conditions
Interventions
This is a randomised controlled trial in which healthy participants are assigned to one of two or more groups and remain in their assigned group for the duration of the study.
This healthy volunteer
Sponsors
Ventyx Biosciences, Inc.
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 07/05/2026: 1. Must provide written informed consent 2. Must be willing and able to communicate and participate in the whole study 3. Aged 18 to 60 years inclusive at the time of signing informed consent 4. Must agree to adhere to the contraception requirements 5. Healthy males 6. Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2 as measured at screening 7. Weight =50.0 kg at screening Previous inclusion criteria: Healthy human volunteer
Exclusion criteria
Exclusion criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 3. Presence of or history of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator 4. History of fits or seizures, including childhood febrile convulsions 5. Subjects with a history of cholecystectomy or gallstones 6. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 7. Evidence of current or history of SARS-CoV-2 infection within 2 weeks of first IMP administration 8. Clinically significant abnormal clinical chemistry, haematology or urinalysis at screening or first admission as judged by the investigator. Subjects with Gilbert’s syndrome are not allowed. 9. Haemoglobin level below the lower limit of the laboratory reference range at screening or first admission 10. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results at screening 11. History of treated, latent or active tuberculosis, including positive QuantiFERON assessed at screening 12. Active or presence of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia), serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicaemia) within 3 months prior to screening 13. Presence or history of fever (body temperature >37.6°C) (e.g., a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dose 14. Subjects who have received any IMP in a clinical research study within the 90 days prior to Period 1, Day 1, or less than 5 elimination half-lives prior to Period 1, Day 1, whichever is longer 15. Subjects who have previously been administered IMP in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2. 16. Donation of blood or plasma within the previous 3 months prior to screening or loss of greater than 400 mL of blood by any other means 17. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 2 g of paracetamol per day) in the 14 days before first IMP administration. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic (PD) activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study.? 18. Subjects who have had a COVID-19 vaccine or any other vaccine 14 days before first IMP administration 19. Subjects who have any plans to travel abroad during the study 20. History of any drug or alcohol abuse in the past 2 years prior to screening 21. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type) 22. A confirmed positive alcohol breath test at screening or first admission 23. Current smokers and those who have smoked within the last
Countries
England, United Kingdom
Contacts
Public ContactNick Higgins
Outcome results
None listed