Study of Single Doses of SBT115301 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SBT115301 in Healthy Participants

Conditions
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Safety

Intervention / Treatment
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* Biological: SBT115301
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Placebo-controlled, sequential escalating dose cohorts
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers, safety