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NCT05388981 · ClinicalTrials.gov registry record · Phase 1
Study of Single Doses of SBT115301 in Healthy Participants
A Phase 1 study, sponsored by Sonoma Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT05388981: Completed Phase 1 study, sponsored by Sonoma Biotherapeutics.
NCT05388981 is a Phase 1 study that has completed, run by Sonoma Biotherapeutics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05388981, a Phase 1 study, has completed, sponsored by Sonoma Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants with treatment-emergent adverse events
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL SBT115301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-07-25 |
| Est. Completion | 2024-01-03 |
| Phase | Phase 1 |
What the finished NCT05388981 record still lists
NCT05388981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05388981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05388981 about?
NCT05388981 is a clinical study titled "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 p...
What is the current status of trial NCT05388981?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-07-25. Estimated completion is 2024-01-03.
What interventions are being tested in trial NCT05388981?
The interventions under investigation include: Placebo (BIOLOGICAL), SBT115301 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05388981?
This trial is sponsored by Sonoma Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05388981's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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