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FB102 Single dose- Part A

Phase 1

Undisclosed | Monoclonal antibody | Other |Forte Biosciences, Inc.|Trials Updated: Oct 21, 2026

FB102 Single dose- Part A target and mechanism

ModalityMonoclonal antibody

Also known as Healthy Volunteer

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

FB102 Single dose- Part A clinical trials

FB102 Single dose- Part A · 1 trial · 1 indication

Phase 1 1
NCT07623057A Study Testing the Safety and Effects of FB102 in Healthy VolunteersHealthy Volunteer
RECRUITING64 Analytics
PHASE1RECRUITING
A Study Testing the Safety and Effects of FB102 in Healthy Volunteers
Healthy Volunteer
NCT0762305764
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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 dose - Part AEXPERIMENTALPart A (single ascending dose, SAD), FB102 will be administered as a single dose.
FB102 Multiple dose - Part BEXPERIMENTALPart 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.
FB102 Multiple dose - Part CEXPERIMENTALPart C (multiple dose), FB102 will be administered once every 2 weeks for 4 doses.

Interventions

NameTypeDescription
FB102 Single dose - Part ABIOLOGICALFB102 will be administered as a single dose
FB102 Multiple doses - Part BBIOLOGICALFB102 will be administered once weekly for 4 doses.
FB102 PlaceboDRUGMatching placebo identical to FB102 formulation but without the active pharmaceutical ingredient
FB102 Multiple doses - Part CBIOLOGICALFB102 will be administered once every 2 weeks for 4 doses.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

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)

MEDIUMOct 21, 2026NCT07623057Enrollment: 48 → 64
MEDIUMOct 21, 2026NCT07623057Enrollment: 48 → 64
MEDIUMOct 21, 2026NCT07623057Enrollment: 48 → 64
LOWAug 20, 2026NCT07623057Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07623057Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07623057Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07623057Status: NOT_YET_RECRUITING → RECRUITING

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