Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05142306 · ClinicalTrials.gov registry record · Phase 1
A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes to SARS-CoV-2 Uninfected Adults
A Phase 1 study, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT05142306 is a Phase 1 study that has completed, run by Emergent BioSolutions. The registered enrollment target is 23 participants.
The verdict
NCT05142306, a Phase 1 study, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
The primary objectives of this open-label trial were to evaluate the safety and pharmacokinetics (PK) of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) administered intramuscularly (IM), subcutaneously (SC), or intravenously (IV) as a single dose in healthy adults 18-59 years of age with body mass index ≤35 kg/m\^2. Prior studies examined IV administration, and the secondary objective of the present study was to compare PK among the three administration routes. No placebo group was included in the phase 1 randomized design. The exploratory objective was to evaluate disease severity in participants that became positive for SARS-CoV-2.
Interventions
- BIOLOGICAL COVID-HIG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-12-07 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05142306
The ClinicalTrials.gov registry entry for NCT05142306 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 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 1 intervention - of which COVID-HIG is the first listed.
NCT05142306 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05142306 about?
NCT05142306 is a clinical study titled "A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes to SARS-CoV-2 Uninfected Adults". The primary objectives of this open-label trial were to evaluate the safety and pharmacokinetics (PK) of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) administered intramuscularly (IM), subcutaneously (SC), or intravenously (IV) as a single dose in healthy adults 18-59 y...
What is the current status of trial NCT05142306?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2021-12-07. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT05142306?
The interventions under investigation include: COVID-HIG (BIOLOGICAL).
Who is sponsoring clinical trial NCT05142306?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.