SafetyPhase 1NCT05388981
Study of Single Doses of SBT115301 in Healthy Participants
A Phase 1 study testing SBT115301 in people with Safety, run by Sonoma Biotherapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- SBT115301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 3 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Safety
- Being tested
- SBT115301, Placebo
- Keywords
- healthy volunteers, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBT115301Biological
Immunomodulatory dimeric fusion protein
PlaceboBiological
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Intramuscular (IM) dose level 1 Receives: Biological: SBT115301; Biological: Placebo |
| Cohort 2 | Experimental | IM dose level 2 Receives: Biological: SBT115301; Biological: Placebo |
| Cohort 3 | Experimental | IM dose level 3 Receives: Biological: SBT115301; Biological: Placebo |
| Cohort 4 | Experimental | IM dose level 4 Receives: Biological: SBT115301; Biological: Placebo |
| Cohort 5 | Experimental | Intravenous (IV) dose level 1 Receives: Biological: SBT115301; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of participants with treatment-emergent adverse events
Measured: 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
Measured: Baseline to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)
Secondary outcomes (7)
SBT115301 Serum Concentration
Serum concentration of SBT115301
Measured: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: Cmax
Maximum serum concentration (Cmax) of SBT115301
Measured: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: Tmax
Time of maximum SBT115301 serum concentration (Tmax)
Measured: 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
Measured: 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
Measured: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Pharmacokinetic Parameters: t1/2
Terminal elimination half-life (t1/2)
Measured: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Anti-Drug Antibodies
Number of participants with anti-drug antibodies
Measured: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start25 Jul 2022
- Primary completion3 Jan 2024
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Placebo-controlled, sequential escalating dose cohorts
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonoma Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Valentine, DO, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388981
- Sponsor's protocol ID
- SBT115301-01
- Status last verified
- Sep 2023
- First submitted
- 19 May 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SBT115301 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05388981
- Acronym / sponsor ID
- SBT115301-01
- Conditions
- Safety
- Keywords
- healthy volunteers, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sonoma Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Placebo-controlled, sequential escalating dose cohorts
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: SBT115301, Biological: PlaceboIntramuscular (IM) dose level 1 |
| Cohort 2 | Experimental | Biological: SBT115301, Biological: PlaceboIM dose level 2 |
| Cohort 3 | Experimental | Biological: SBT115301, Biological: PlaceboIM dose level 3 |
| Cohort 4 | Experimental | Biological: SBT115301, Biological: PlaceboIM dose level 4 |
| Cohort 5 | Experimental | Biological: SBT115301, Biological: PlaceboIntravenous (IV) dose level 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBT115301Immunomodulatory dimeric fusion protein | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboMatched placebo | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
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
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
7 secondary outcomes
SBT115301 Serum Concentration
Time frame: 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)
Pharmacokinetic Parameters: Tmax
Time frame: 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)
Pharmacokinetic Parameters: AUC(0-inf)
Time frame: 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)
Anti-Drug Antibodies
Time frame: Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Valentine, DO principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SBT115301 in people with Safety, run by Sonoma Biotherapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Day of treatment to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.