Study of Single Doses of SBT115301 in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety

In brief

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.

Key facts

Study ID

NCT05388981

Run by

Sonoma Biotherapeutics, Inc.

People needed

40

Starts

2022-07-25

Expected to finish

2024-01-03

Last updated by the study team

2024-09-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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