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SL-325

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |Shattuck Labs, Inc.|Last Updated: Apr 30, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07158437Phase 1 Study of SL-325 in Healthy VolunteersPHASE1 ACTIVE NOT_RECRUITING 72Sep 18, 2025Jul 1, 2026Apr 30, 20261 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability
Day 1 through 75 days after last dose

Incidence and severity of treatment-emergent adverse events

Secondary Endpoints
Pharmacokinetics (PK): Cmax
Day 1 through 75 days after last dose
Pharmacokinetics (PK): Tmax
Day 1 through 75 days after last dose
Pharmacokinetics (PK): Ctrough
Day 1 through 75 days after last dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAD: SL-325EXPERIMENTALParticipants will receive a single dose of SL-325 in escalating dose cohorts
SAD: PlaceboPLACEBO_COMPARATORParticipants will receive a single dose of placebo (normal saline)
MAD: SL-325EXPERIMENTALParticipants will receive a three doses of SL-325 in escalating dose cohorts
MAD: PlaceboPLACEBO_COMPARATORParticipants will receive a three doses of placebo (normal saline)
Interventions
NameTypeDescription
SL-325BIOLOGICALDR3 blocking antibody
Placebo (Normal Saline)OTHERNormal saline
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provide signed informed consent 2. 18-55 years of age, inclusive, at the time of signing the informed consent form 3. Body mass index of 18-32 kg/m2, inclusive, and a total body weight \> 50 kg 4. Laboratory values within normal limits or any abnormalities deemed not clinical...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07158437Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07158437studyFirstPostDate: changed