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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: Completed Phase 1 study of Chikungunya Virus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of participants who experienced at least one unsolicited AE. An AE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baselin
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 |
What the finished NCT04441905 record still lists
NCT04441905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 447-participant average among 4 other Chikungunya Virus Infection trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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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