A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 4

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05522517
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Cosentyx — DRUG
    Cosentyx injection will be administered subcutaneously.
  • Candin — DRUG
    Candin will be administered interadermally along with NaCl solution.

Study Details

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.

Key Dates

Start date
Aug 22, 2022
Status verified
Jan 2025
Primary completion
Nov 2, 2022
Completion
Nov 2, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Candin + Cosentyx
    Participants will receive a single dose of candin injection intradermally on Day 6 along with a single dose of saline solution injection of 0.9 percent (%) sodium chloride (NaCl) and a single dose of Cosentyx injection subcutaneously on Day 1.
  • No Intervention: Candin Challenge
    All participants will receive single dose of candin injection intradermally on Day 6 along with a single dose of saline solution injection of 0.9 percent (%) sodium chloride (NaCl) administered intradermally and no Cosentyx.

Primary Outcome Measure

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 [ Time Frame: Day 7 ]

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