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NCT04468958 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants
A Phase 1 study, sponsored by SAb Biotherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT04468958: Completed Phase 1 study, sponsored by SAb Biotherapeutics.
NCT04468958 is a Phase 1 study that has completed, run by SAb Biotherapeutics. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04468958, a Phase 1 study, has completed, sponsored by SAb Biotherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic \[Tc\] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.
Primary Outcome
Incidence and severity of other adverse events and severe adverse events (SAE)
Interventions
- OTHER Normal saline
- BIOLOGICAL SAB-185
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 1 |
What the finished NCT04468958 record still lists
NCT04468958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT04468958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04468958 about?
NCT04468958 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants". Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic \[Tc\] bovine-derived), as a potential therapeutic to ...
What is the current status of trial NCT04468958?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2020-07-01. Estimated completion is 2020-12-23.
What interventions are being tested in trial NCT04468958?
The interventions under investigation include: Normal saline (OTHER), SAB-185 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04468958?
This trial is sponsored by SAb Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04468958's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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