Status:
COMPLETED
Study of Single Doses of SBT115301 in Healthy Participants
Lead Sponsor:
Sonoma Biotherapeutics, Inc.
Conditions:
Safety
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05388981
Start Date
July 25 2022
End Date
January 3 2024
Last Update
September 25 2024
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283