Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
Public ClinicalTrials.gov record NCT05976386. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-label, Parallel Design, Single Dose Study to Compare the Pharmacokinetics of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05976386
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 182 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 7, 2021
- Primary completion
- Sep 23, 2021
- Completion
- Sep 23, 2021
- Last update posted
- Sep 18, 2025
2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Pharmacology of Miami-Site Number:8400001 | Miami | Florida | 33014 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05976386, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2025 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05976386 live on ClinicalTrials.gov.