Recent Updates
Recently added Catalysts

SBT115301

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

SBT115301 · 1 trial · 1 indication

Phase 1 1
NCT05388981Study of Single Doses of SBT115301 in Healthy ParticipantsSafety
COMPLETED40 Analytics
PHASE1COMPLETED
Study of Single Doses of SBT115301 in Healthy Participants
Safety
NCT0538898140
Unlock trial analytics

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)
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about SBT115301

What is SBT115301?

SBT115301 is an investigational monoclonal antibody being developed by Sonoma Pharmaceuticals, Inc. It is currently in Phase 1 clinical development. The drug is being studied for safety in healthy participants, and it has completed one clinical trial.

What does SBT115301 target?

SBT115301 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for safety in healthy participants, and its mechanism of action is not publicly detailed.

Who makes SBT115301?

SBT115301 is being developed by Sonoma Pharmaceuticals, Inc., a company traded under the ticker symbol SNOA. The drug is currently in Phase 1 clinical development.

What phase is SBT115301 in?

SBT115301 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for safety in healthy participants.

What clinical trials is SBT115301 in?

SBT115301 has one completed clinical trial, NCT05388981, titled 'Study of Single Doses of SBT115301 in Healthy Participants.' This Phase 1 trial enrolled 40 participants in the United States and was a randomized, double-blind, controlled study.

Is SBT115301 the same as any other drug?

SBT115301 is not known by any alternative names. It is a distinct investigational monoclonal antibody being developed by Sonoma Pharmaceuticals, Inc. for safety evaluation in healthy participants.