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NCT05976386 · ClinicalTrials.gov registry record · Phase 1
Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
A Phase 1 study of Healthy Volunteers, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 182
- Enrollment target
- 1
- Study location
NCT05976386 is a Phase 1 study of Healthy Volunteers that has completed, run by Sanofi. The registered enrollment target is 182 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05976386, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 182 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in male and female healthy participants aged 18 to 65 years. The estimated duration is up to 21 days of screening period, followed by the treatment day with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total duration from screening to EOS will be 64 days maximum.
Conditions Studied
Interventions
- DRUG Dupilumab (SAR231893)
Study Locations (1)
Florida
- Clinical Pharmacology of Miami-Site Number:8400001 - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2021-06-08 |
| Est. Completion | 2021-09-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05976386
The ClinicalTrials.gov registry entry for NCT05976386 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (62% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab (SAR231893) is the first listed.
NCT05976386 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT05976386 about?
NCT05976386 is a clinical study titled "Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults". This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in male and female healthy participants aged 18 to 65 years. The estimate...
What is the current status of trial NCT05976386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 182 participants. The study started on 2021-06-08. Estimated completion is 2021-09-24.
What conditions does trial NCT05976386 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05976386?
The interventions under investigation include: Dupilumab (SAR231893) (DRUG).
Who is sponsoring clinical trial NCT05976386?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05976386 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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