Safety
Conditions
Keywords
healthy volunteers, safety
Brief 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.
Interventions
BIOLOGICALSBT115301
Immunomodulatory dimeric fusion protein
BIOLOGICALPlacebo
Matched placebo
Sponsors
Sonoma Biotherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Placebo-controlled, sequential escalating dose cohorts
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameters: Tmax | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) | Time of maximum SBT115301 serum concentration (Tmax) |
| Pharmacokinetic Parameters: AUC(0-last) | 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 |
| Pharmacokinetic Parameters: Cmax | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) | Maximum serum concentration (Cmax) of SBT115301 |
| Pharmacokinetic Parameters: t1/2 | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) | Terminal elimination half-life (t1/2) |
| Anti-Drug Antibodies | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) | Number of participants with anti-drug antibodies |
| Pharmacokinetic Parameters: AUC(0-inf) | 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 |
| SBT115301 Serum Concentration | Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5) | Serum concentration of SBT115301 |
Countries
United States
Outcome results
None listed