NCT05388981

Study of Single Doses of SBT115301 in Healthy Participants

A Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SBT115301 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sonoma Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	SBT115301	Immunomodulatory dimeric fusion protein
BIOLOGICAL	Placebo	Matched placebo

Timeline

• Start date: 2022-07-25
• Primary completion: 2024-01-03
• Completion: 2024-01-03
• First posted: 2022-05-24
• Last updated: 2024-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study