Study of Single Doses of SBT115301 in Healthy Participants

Sonoma Biotherapeutics

Status and phase: Completed; Phase 1

Conditions: Safety

Treatments: Biological: Placebo; Biological: SBT115301

Study type: Interventional

Funder types: Industry

Identifiers

NCT05388981

SBT115301-01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Intramuscular (IM) dose level 1

Treatment:

Biological: SBT115301

Biological: Placebo

Cohort 2

Experimental group

Description:

IM dose level 2

Treatment:

Biological: SBT115301

Biological: Placebo

Cohort 3

Experimental group

Description:

IM dose level 3

Treatment:

Biological: SBT115301

Biological: Placebo

Cohort 4

Experimental group

Description:

IM dose level 4

Treatment:

Biological: SBT115301

Biological: Placebo

Cohort 5

Experimental group

Description:

Intravenous (IV) dose level 1

Treatment:

Biological: SBT115301

Biological: Placebo