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NCT04519437 · ClinicalTrials.gov registry record · Phase 1
Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19
A Phase 1 study of Healthy and Chronic Stable Illness, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 974
- Enrollment target
- 7
- Study locations
NCT04519437 is a Phase 1 study of Healthy and Chronic Stable Illness that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 974 participants, above the 646-participant average among 1,090 other Healthy trials with a reported enrollment target (51% higher). The trial reports 7 study locations across 7 states.
The verdict
NCT04519437, a Phase 1 study of Healthy and Chronic Stable Illness, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 974 participants
- Enrollment target
- 7
- Study locations
Study Summary
The primary objectives are: * To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo * To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration The secondary objectives are: * To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo * To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration * To assess the immunogenicity of REGN10933 and REGN10987
Conditions Studied
Interventions
- DRUG Placebo
- DRUG REGN10933+REGN10987
Study Locations (7)
Arizona
- Regeneron Study Site - Tempe
Arkansas
- Regeneron Study Site - Rogers
California
- Regeneron Study Site - Sacramento
Florida
- Regeneron Study Site - Miami
Nebraska
- Regeneron Study Site - Lincoln
Ohio
- Regeneron Study Site - Dayton
Texas
- Regeneron Study Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 974 participants |
| Start Date | 2020-07-26 |
| Est. Completion | 2021-11-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04519437
The ClinicalTrials.gov registry entry for NCT04519437 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 974 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 646-participant average among 1,090 other Healthy trials with a reported enrollment target (51% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04519437 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Arizona, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT04519437 about?
NCT04519437 is a clinical study titled "Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19". The primary objectives are: * To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo * To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and...
What is the current status of trial NCT04519437?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 974 participants. The study started on 2020-07-26. Estimated completion is 2021-11-22.
What conditions does trial NCT04519437 study?
This clinical trial studies the following conditions: Healthy, Chronic Stable Illness.
What interventions are being tested in trial NCT04519437?
The interventions under investigation include: Placebo (DRUG), REGN10933+REGN10987 (DRUG).
Who is sponsoring clinical trial NCT04519437?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04519437 being conducted?
This trial has 7 study locations across Arizona, Arkansas, California, Florida, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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