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SBT115301

Phase 1

Safety | Monoclonal antibody | Other |Sonoma Pharmaceuticals, Inc.|Last Updated: Sep 25, 2024

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 Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05388981Study of Single Doses of SBT115301 in Healthy ParticipantsPHASE1 COMPLETED 40 — — Jul 25, 2022Jan 3, 2024Sep 25, 20241 United States
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Study Endpoints
Primary Endpoints
Adverse events
Day of treatment to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)

Number of participants with treatment-emergent adverse events

Serious adverse events
Baseline to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)

Number of participants with serious adverse events

Secondary Endpoints
SBT115301 Serum Concentration
Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: Cmax
Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: Tmax
Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALIntramuscular (IM) dose level 1
Cohort 2EXPERIMENTALIM dose level 2
Cohort 3EXPERIMENTALIM dose level 3
Cohort 4EXPERIMENTALIM dose level 4
Cohort 5EXPERIMENTALIntravenous (IV) dose level 1
Interventions
NameTypeDescription
SBT115301BIOLOGICALImmunomodulatory dimeric fusion protein
PlaceboBIOLOGICALMatched placebo
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males or females not of childbearing potential * Healthy participants based on medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory tests * Use of highly effective methods of contraception (sexually active males with partners of childb...

Countries:United States
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