Study of Single Doses of SBT115301 in Healthy Participants

September 23, 2024 updated by: Sonoma Biotherapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Day of treatment to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)
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
Time Frame: Baseline to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SBT115301 Serum Concentration
Time Frame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Serum concentration of SBT115301
Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: Cmax
Time Frame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Maximum serum concentration (Cmax) of SBT115301
Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: Tmax
Time Frame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
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)
Time Frame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
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)
Time Frame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
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
Time Frame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Terminal elimination half-life (t1/2)
Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Anti-Drug Antibodies
Time Frame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Number of participants with anti-drug antibodies
Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sonoma Biotherapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle Valentine, DO, Celerion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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