Healthy
Conditions
Brief 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.
Interventions
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of no less than 50 kilograms (kg) * Otherwise healthy on the basis of physical examination, medical history, and vital signs, and if required by the applicable Intervention Specific Appendix (ISA), a 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant or consistent with the disease of interest, as specified in the applicable ISA. This determination must be recorded in the participant's source documents and initialed by the investigator * Otherwise healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator * Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 \[COVID-19\]) reverse transcription polymerase chain reaction (RT-PCR) test within 72 hours prior to administration of study intervention * A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 20 weeks after study intervention administration
Exclusion criteria
* History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances, unless consistent with the underlying disease of interest in the study population, if applicable * History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia, unless consistent with the underlying disease of interest in the study population, if applicable. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease * Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Known allergies, hypersensitivity, or intolerance to secukinumab or its excipients * Has surgery planned within 20 weeks after the study intervention administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Presence and Size of Induration in Active Versus Control at the Candin Injection Site Compared to the Intra-individual Saline Control Injection Site Between 6 and 96 Hours After Candin Challenge | Day 7 | Number of participants with presence and size of induration in active versus control at the Candin injection site compared to the intra-individual saline control injection site between 6 and 96 hours after Candin challenge will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) in the Active Arm Versus the Control Arm | Up to Day 30 | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. |
| Number of Participants with Treatment-emergent Serious Adverse Events (SAEs) in the Active Arm Versus the Control Arm | Up to Day 30 | A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state. |
| Number of Participants with TEAEs by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More in the Active Arm Versus the Control Arm | Up to Day 30 | Number of participants with TEAEs by MedDRA SOC with a frequency threshold of 5% or more in the active arm versus the control arm will be reported. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. |
Countries
Belgium
Outcome results
None listed