Study of Single Doses of SBT115301 in Healthy Participants

Phase 1

Active, not recruiting

• Conditions: Safety
• Interventions: Biological: SBT115301; Biological: Placebo

• Registration Number: NCT05388981
• Lead Sponsor: Sonoma Biotherapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Study Start: 2022-07-25
• Status Verified: 2023-09
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Placebo	Intramuscular (IM) dose level 1
Cohort 3	SBT115301	IM dose level 3
Cohort 3	Placebo	IM dose level 3
Cohort 5	Placebo	Intravenous (IV) dose level 1
Cohort 4	Placebo	IM dose level 4
Cohort 1	SBT115301	Intramuscular (IM) dose level 1
Cohort 2	SBT115301	IM dose level 2
Cohort 2	Placebo	IM dose level 2
Cohort 4	SBT115301	IM dose level 4
Cohort 5	SBT115301	Intravenous (IV) dose level 1

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameters: t1/2	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)	Terminal elimination half-life (t1/2)
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
Anti-Drug Antibodies	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)	Number of participants with anti-drug antibodies
SBT115301 Serum Concentration	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)	Serum concentration of SBT115301
Pharmacokinetic Parameters: Cmax	Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)	Maximum serum concentration (Cmax) of SBT115301
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

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States