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Study of Single Doses of SBT115301 in Healthy Participants

NCT05388981 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-09-25

No results posted yet for this study

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.

Conditions

  • Safety

Interventions

BIOLOGICAL

SBT115301

Immunomodulatory dimeric fusion protein

BIOLOGICAL

Placebo

Matched placebo

Sponsors & Collaborators

  • Sonoma Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michelle Valentine, DO · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2024-01-03
Completion
2024-01-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388981 on ClinicalTrials.gov