A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3

NCT ID: NCT04985955

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2021-09-21

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Candin + Tofacitinib

Participants will receive a single dose of Candin injection on forearm of 1 arm along with a saline solution injection of 0.9 percent (%) sodium chloride (NaCl) on the opposite forearm on Day 3 and oral dose of tofacitinib for 5 days.

Group Type: EXPERIMENTAL

Tofacitinib

Intervention Type: DRUG

Tofacitinib tablet will be administered orally.

Candin Challenge

All participants will receive a single dose of Candin injection on forearm of 1 arm along with a saline solution injection of 0.9% NaCl on the opposite forearm on Day 3.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tofacitinib

Tofacitinib tablet will be administered orally.

Intervention Type: DRUG

Other Intervention Names

Xeljanz

Eligibility Criteria

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)
• Healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
• 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
• Must sign an informed consent forms (ICFs) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 30 days after the last dose of study intervention

Exclusion Criteria

• History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic, or mucocutaneous disturbances
• History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia. 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 (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Has experienced a recent single dermatomal herpes zoster eruption within the past 6 months or has had multi-dermatomal herpes zoster or central nervous system zoster within the past 5 years
• Has surgery planned within 30 days after study intervention administration

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2020-006066-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NOPRODPANAP1003

Identifier Type: OTHER

Identifier Source: secondary_id

PLATFORMPANAP1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR109020

Identifier Type: -

Identifier Source: org_study_id