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NCT04661839 · ClinicalTrials.gov registry record · Phase 1
A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT04661839 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 28 participants.
The verdict
NCT04661839, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with 84 days of safety and PK follow-up post-administration.
Interventions
- OTHER Placebo (saline)
- BIOLOGICAL COVID-HIGIV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-12-24 |
| Est. Completion | 2021-07-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04661839
The ClinicalTrials.gov registry entry for NCT04661839 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo (saline) is the first listed.
NCT04661839 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04661839 about?
NCT04661839 is a clinical study titled "A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults". This study is designed to evaluate three dose levels of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) (COVID-HIGIV) for safety and pharmacokinetics (PK) in healthy adults. Twenty-eight healthy adult subjects will be enrolled into the study to receive a single dose of COVID-HIGIV or placebo with...
What is the current status of trial NCT04661839?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2020-12-24. Estimated completion is 2021-07-27.
What interventions are being tested in trial NCT04661839?
The interventions under investigation include: Placebo (saline) (OTHER), COVID-HIGIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT04661839?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
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