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

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.

Study Overview

• Status: Completed
• Conditions: Safety
• Intervention / Treatment: Biological: Placebo; Biological: SBT115301

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Intramuscular (IM) dose level 1	Biological: Placebo; Matched placebo; Biological: SBT115301; Immunomodulatory dimeric fusion protein
Experimental: Cohort 2; IM dose level 2	Biological: Placebo; Matched placebo; Biological: SBT115301; Immunomodulatory dimeric fusion protein
Experimental: Cohort 3; IM dose level 3	Biological: Placebo; Matched placebo; Biological: SBT115301; Immunomodulatory dimeric fusion protein
Experimental: Cohort 4; IM dose level 4	Biological: Placebo; Matched placebo; Biological: SBT115301; Immunomodulatory dimeric fusion protein
Experimental: Cohort 5; Intravenous (IV) dose level 1	Biological: Placebo; Matched placebo; Biological: SBT115301; Immunomodulatory dimeric fusion protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of participants with treatment-emergent adverse events	Day of treatment to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)
Serious adverse events	Number of participants with serious adverse events	Baseline to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SBT115301 Serum Concentration	Serum concentration of SBT115301	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: Cmax	Maximum serum concentration (Cmax) of SBT115301	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: Tmax	Time of maximum SBT115301 serum concentration (Tmax)	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: AUC(0-last)	Area under the serum concentration-time curve (AUC) from time 0 to the last measurable serum concentration	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: AUC(0-inf)	Area under the serum concentration-time curve from time 0 extrapolated to infinity	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: t1/2	Terminal elimination half-life (t1/2)	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Anti-Drug Antibodies	Number of participants with anti-drug antibodies	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)

Collaborators and Investigators

• Sponsor: Sonoma Biotherapeutics, Inc.
• Investigators: Principal Investigator: Michelle Valentine, DO, Celerion

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): January 3, 2024
• Study Completion (Actual): January 3, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: safety; healthy volunteers
• Other Study ID Numbers: SBT115301-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No