A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 1

• Status: Completed
• Trial end date: 2021-05-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response at the site of Candin intradermal injection in the presence of a targeted immune pathway inhibitor.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Body mass index (BMI) between 18 and 30 kilogram per square centimeter (kg/m^2) (BMI = weight/height^2), inclusive, and a body weight of no less than 50 kg

• Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (eg, nicotine patch) for 3 months prior to screening

• Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) coronavirus disease 2019 (COVID-19) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to administration of study intervention

• Are considered eligible according to the following tuberculosis (TB) screening criteria: have no history of latent or active TB prior to screening, have no signs or symptoms suggestive of active TB upon medical history and/or physical examination, and have had no recent close contact with a person with active TB

• Have a negative T-Spot TB test or QuantiFERON-TB test result within 28 days prior to the first administration of study intervention. A negative tuberculin skin test prior to the first study intervention administration is additionally required if the T-Spot test or QuantiFERON-TB test is not approved/registered in that country or the tuberculin skin test is mandated by local health authorities. If the test is positive, the participant will be referred for appropriate follow-up; however, these participants will not be included in the study

Exclusion Criteria:

• History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances

• Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis) or has been hospitalized for a serious infection during the 6 months prior to screening

• Has received over-the-counter medications (including vitamins/multivitamins/supplements, corticosteroids, acetaminophen/paracetamol aspirin, decongestants, antihistamines, and other non-steroidal anti-inflammatory drugs), and herbal medication (including, but not limited to, herbal tea and St. John's Wort) within 2 weeks prior to first study treatment administration unless approved by the investigator and sponsor medical monitor

• Has surgery planned within 20 weeks after the study intervention administration

• Has had prior exposure to secukinumab or other interleukin-17 inhibitors, such as ixekizumab, brodalumab, bimekizumab