Skip to main content
OpenTrials
Completed

NCT Number: NCT05388981

Study of Single Doses of SBT115301 in Healthy Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Safety

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBT115301

Biological

Immunomodulatory dimeric fusion protein

Placebo

Biological

Matched placebo

Primary outcomes

  1. Adverse events

    Time frame: 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

  2. Serious adverse events

    Time frame: 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 outcomes

  1. SBT115301 Serum Concentration

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

    Serum concentration of SBT115301

  2. Pharmacokinetic Parameters: Cmax

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

    Maximum serum concentration (Cmax) of SBT115301

  3. Pharmacokinetic Parameters: Tmax

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

    Time of maximum SBT115301 serum concentration (Tmax)

  4. Pharmacokinetic Parameters: AUC(0-last)

    Time frame: 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

  5. Pharmacokinetic Parameters: AUC(0-inf)

    Time frame: 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

  6. Pharmacokinetic Parameters: t1/2

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

    Terminal elimination half-life (t1/2)

  7. Anti-Drug Antibodies

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

    Number of participants with anti-drug antibodies

Sponsors and collaborators

Lead sponsor

Sonoma Biotherapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 24, 2022
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.