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FB102 Single dose

Phase 1

Healthy Volunteer | Small molecule | Other |Forte Biosciences, Inc.|Last Updated: Jun 3, 2026

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07623057A Study Testing the Safety and Effects of FB102 in Healthy VolunteersPHASE1 NOT YET_RECRUITING 56 — — Jun 1, 2026Feb 1, 2027Jun 3, 20261 Australia
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Study Endpoints
Primary Endpoints
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs)
From day 1 to Day 85 (End of treatment visit)
Incidence, severity, and relationship to treatment of SAEs
From day 1 to Day 85 (End of treatment visit)
Secondary Endpoints
Plasma PK parameters for single dose- maximum serum concentration (Cmax)
Day 1,2,3,4,5,8,15,22,36,50,85
Plasma PK parameters for single dose- time to maximum concentration (Tmax)
Day 1,2,3,4,5,8,15,22,36,50,85
Plasma PK parameters for Multiple dose- maximum serum concentration (Cmax)
Days 1 and 22
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FB102 Single doseEXPERIMENTALPart A (single ascending dose, SAD), FB102 will be administered as a single dose.
FB102 Multiple doseEXPERIMENTALPart B (multiple ascending dose, MAD), FB102 will be administered once weekly for 4 doses.
FB102 PlaceboPLACEBO_COMPARATORThe placebo will be administered on the same schedule as the corresponding FB-102 cohort.
Interventions
NameTypeDescription
FB102 Single doseDRUGFB102 will be administered as a single dose
FB102 Multiple dosesDRUGFB102 will be administered once weekly for 4 doses.
FB102 PlaceboDRUGMatching placebo identical to FB102 formulation but without the active pharmaceutical ingredient
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening. 2. Weight ≥50 kg and ≤100kg. 3. Men are required to agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal co...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07623057NEW_TRIAL: changed
LOWJun 4, 2026NCT07623057NEW_TRIAL: changed
LOWJun 4, 2026NCT07623057NEW_TRIAL: changed
LOWJun 4, 2026NCT07623057NEW_TRIAL: changed
LOWJun 4, 2026NCT07623057NEW_TRIAL: changed