Study of Single Doses of SBT115301 in Healthy Participants

Safety Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05388981
• Other study ID #: SBT115301-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 25, 2022
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Sonoma Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Some participants will receive placebo, and neither the participants or the study staff will know what drug (SBT115301 or placebo) is being given.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety

Intervention

Biological:
• SBT115301
Immunomodulatory dimeric fusion protein
• Placebo
Matched placebo

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Sonoma Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	SBT115301 Serum Concentration	Serum concentration of SBT115301	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Secondary	Pharmacokinetic Parameters: Cmax	Maximum serum concentration (Cmax) of SBT115301	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Secondary	Pharmacokinetic Parameters: Tmax	Time of maximum SBT115301 serum concentration (Tmax)	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Secondary	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)
Secondary	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)
Secondary	Pharmacokinetic Parameters: t1/2	Terminal elimination half-life (t1/2)	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)
Secondary	Anti-Drug Antibodies	Number of participants with anti-drug antibodies	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)