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JNJ-63733657

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 28, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05407818A Study of JNJ-63733657 in Healthy Chinese ParticipantsPHASE1 COMPLETED 10 — — Jun 27, 2022Nov 7, 2022Apr 27, 20251 China
NCT03689153A Study of JNJ-63733657 in Healthy Japanese ParticipantsPHASE1 COMPLETED 24 — — Sep 28, 2018Jul 11, 2019Apr 28, 20251 Japan
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Study Endpoints
Primary Endpoints
Serum Concentrations of JNJ-63733657
Up to Week 13

Serum samples will be analyzed to determine concentrations of JNJ-63733657 using a validated, specific, and sensitive Immunoassay method.

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Approximately 23 weeks

An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Secondary Endpoints
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
Up to Week 13
Percentage of Participants with Discontinuations due to AEs
Up to Week 17
Percentage of Participants with Serious Adverse Events (SAEs)
Up to Week 17
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
JNJ-63733657EXPERIMENTALParticipants will receive a single dose of JNJ-63733657 as an intravenous (IV) infusion on Day 1.
Cohort 1: JNJ-63733657 or PlaceboEXPERIMENTALParticipants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo.
Cohort 2: JNJ-63733657 or PlaceboEXPERIMENTALParticipants will receive a single IV middle dose of JNJ-63733657 or matching placebo.
Cohort 3: JNJ-63733657 or PlaceboEXPERIMENTALParticipants will receive a single IV high dose of JNJ-63733657 or matching placebo.
Interventions
NameTypeDescription
JNJ-63733657DRUGJNJ-63733657 will be administered as an IV infusion.
PlaceboDRUGParticipants will receive matching placebo intravenously.
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Eligibility Criteria
Age Range55 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy for their age group on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. If there are any abnormalities, they must be considered not clinically relevant and this determination must be recorded...

Countries:ChinaJapan
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