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NCT04441905 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of SAR440894 vs Placebo
A Phase 1 study of Chikungunya Virus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 3
- Study locations
NCT04441905 is a Phase 1 study of Chikungunya Virus Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 42 participants, below the 447-participant average among 4 other Chikungunya Virus Infection trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT04441905, a Phase 1 study of Chikungunya Virus Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 3
- Study locations
Study Summary
A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults aged 18 to 45, inclusive, will be recruited and admitted at multiple sites. Each subject will be randomized to receive either SAR440894 or matching placebo via 60-minute intravenous infusion. In each cohort of 8 subjects, the randomization ratio will be 6 active to 2 placebo, and 2 sentinel subjects (one from each active and placebo group) will be dosed first. Dosing of the next dose-cohort will be dependent on acceptable meeting predefined safety criteria in the preceding cohort. Each subject's participation will take place over approximately 150 days, not including the screening visit. There are no hypotheses for this phase I study. The primary objective will be to determine the safety of single ascending intravenous (IV) infusions of SAR440894 when administered in healthy adults.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL SAR440894
Study Locations (3)
Florida
- Pharmaceutical Product Development - Orlando Clinical Research Unit - Orlando
North Carolina
- Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit - Durham
Texas
- PPD - Austin Clinical Research Unit - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2024-08-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04441905
The ClinicalTrials.gov registry entry for NCT04441905 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 447-participant average among 4 other Chikungunya Virus Infection trials with a reported enrollment target (91% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chikungunya Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04441905 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT04441905 about?
NCT04441905 is a clinical study titled "Phase 1 Study of SAR440894 vs Placebo". A single, ascending-dose design with five dose-cohorts of 8 subjects. Forty healthy adults aged 18 to 45, inclusive, will be recruited and admitted at multiple sites. Each subject will be randomized to receive either SAR440894 or matching placebo via 60-minute intravenous infusion. In each cohort of...
What is the current status of trial NCT04441905?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2020-10-14. Estimated completion is 2024-08-22.
What conditions does trial NCT04441905 study?
This clinical trial studies the following conditions: Chikungunya Virus Infection.
What interventions are being tested in trial NCT04441905?
The interventions under investigation include: Placebo (OTHER), SAR440894 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04441905?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04441905 being conducted?
This trial has 3 study locations across Florida, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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