Study of Single Doses of SBT115301 in Healthy Participants

NCT05388981 | Completed Phase 1 FDA Drug

• 1 other identifier: SBT115301-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety

Keywords

healthy volunteers; safety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• SBT115301 Serum Concentration

  Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)

• Pharmacokinetic Parameters: Cmax

  Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)

• Pharmacokinetic Parameters: Tmax

  Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)

• Pharmacokinetic Parameters: AUC(0-last)

  Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)

• Pharmacokinetic Parameters: AUC(0-inf)

  Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5)

Study Arms (5)

Cohort 1

EXPERIMENTAL

Intramuscular (IM) dose level 1

Biological: SBT115301; Biological: Placebo

Cohort 2

EXPERIMENTAL

IM dose level 2

Biological: SBT115301; Biological: Placebo

Cohort 3

EXPERIMENTAL

IM dose level 3

Biological: SBT115301; Biological: Placebo

Cohort 4

EXPERIMENTAL

IM dose level 4

Biological: SBT115301; Biological: Placebo

Cohort 5

EXPERIMENTAL

Intravenous (IV) dose level 1

Biological: SBT115301; Biological: Placebo

Interventions

SBT115301 BIOLOGICAL

Immunomodulatory dimeric fusion protein

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Placebo BIOLOGICAL

Matched placebo

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonoma Biotherapeutics, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Study Officials

• Michelle Valentine, DO

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, sequential escalating dose cohorts

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: July 25, 2022
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: September 25, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)