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Candin

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Feb 3, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials3
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Candin · 3 trials · 1 indication

Phase 1 3
NCT05522517A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 4Healthy
COMPLETED20 Analytics
NCT04611971A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2Healthy
COMPLETED13 Analytics
NCT04589026A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 1Healthy
COMPLETED12 Analytics
PHASE1COMPLETED
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 4
Healthy
NCT0552251720
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PHASE1COMPLETED
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2
Healthy
NCT0461197113
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PHASE1COMPLETED
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 1
Healthy
NCT0458902612
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Study Endpoints

Primary Endpoints

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.

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 Approximately 48 Hours After Candin Challenge
Day 8

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 approximately 48 hours after Candin challenge will be reported.

Secondary Endpoints

Number of Participants with Treatment-emergent Adverse Events (TEAEs) in the Active Arm Versus the Control Arm
Up to Day 30
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs) in the Active Arm Versus the Control Arm
Up to Day 30
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Candin + CosentyxEXPERIMENTALParticipants 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.
Candin ChallengeNO_INTERVENTIONAll 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.
Active Arm: Benlysta + CandinACTIVE_COMPARATORParticipants will receive a single dose of Candin injection intradermally along with a saline solution of 0.9% sodium chloride (NaCl), and a single dose of Benlysta injection subcutaneously.
Control Arm: CandinNO_INTERVENTIONAll participants will receive a single dose of Candin injection intradermally along with a single dose of saline solution of 0.9% NaCl administered intradermally and no Benlysta.
Active Arm: Candin + ConsentyxACTIVE_COMPARATORParticipants will receive a single dose of Candin injection intradermally along with a saline solution of 0.9% sodium chloride (NaCl), and a single dose of Cosentyx injection subcutaneously.

Interventions

NameTypeDescription
CosentyxDRUGCosentyx injection will be administered subcutaneously.
CandinDRUGCandin will be administered interadermally along with NaCl solution.
BenlystaDRUGBenlysta injection will be administered subcutaneously.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 requi...

Countries:Belgium
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