A Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SBT115301 in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Sonoma Biotherapeutics, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Serious adverse events
Study Overview
Brief Summary
This study will test the safety and effects of SBT115301 when given as a single dose to healthy adult volunteers. It is the first study being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Some participants will receive placebo, and neither the participants or the study staff will know what drug (SBT115301 or placebo) is being given.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 childbearing potential)
- •Up-to-date vaccinations for coronavirus disease (COVID-19) and influenza
Exclusion Criteria
- •Chronic or acute illness
- •History of drug or alcohol abuse or positive drug or alcohol screening results
- •Clinically significant ECG abnormality
- •Received attenuated live vaccine within 1 month or COVID-19 vaccine within 2 weeks prior to study, or anticipated vaccination during study period
Arms & Interventions
Cohort 3
IM dose level 3
Intervention: Placebo (Biological)
Cohort 4
IM dose level 4
Intervention: SBT115301 (Biological)
Cohort 1
Intramuscular (IM) dose level 1
Intervention: SBT115301 (Biological)
Cohort 1
Intramuscular (IM) dose level 1
Intervention: Placebo (Biological)
Cohort 2
IM dose level 2
Intervention: SBT115301 (Biological)
Cohort 2
IM dose level 2
Intervention: Placebo (Biological)
Cohort 3
IM dose level 3
Intervention: SBT115301 (Biological)
Cohort 4
IM dose level 4
Intervention: Placebo (Biological)
Cohort 5
Intravenous (IV) dose level 1
Intervention: SBT115301 (Biological)
Cohort 5
Intravenous (IV) dose level 1
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
Serious adverse events
Time Frame: 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
Adverse events
Time Frame: 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
Secondary Outcomes
- Pharmacokinetic Parameters: Tmax(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- Pharmacokinetic Parameters: AUC(0-last)(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- Pharmacokinetic Parameters: t1/2(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- Anti-Drug Antibodies(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- 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: AUC(0-inf)(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))