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NCT07646548 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
A Phase 1 study, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT07646548 is a Phase 1 study that is actively recruiting participants, run by Sanofi. The registered enrollment target is 40 participants.
The verdict
NCT07646548, a Phase 1 study, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab without berahyaluronidase alfa. The purpose of this study is to assess the pharmacokinetic (PK) characteristics of a single SC dose of dupilumab coformulated with berahyaluronidase alfa and dupilumab without berahyaluronidase alfa in healthy participants aged ≥18 and ≤60 years. Study details include: * The study duration will be approximately up to 12 to 15 weeks. * The treatment will be administered as a single dose on Day 1. * The number of visits will be 14.
Interventions
- BIOLOGICAL Dupilumab
- BIOLOGICAL Dupilumab coformulated with berahyaluronidase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-06-11 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07646548
The ClinicalTrials.gov registry entry for NCT07646548 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dupilumab is the first listed.
NCT07646548 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07646548 about?
NCT07646548 is a clinical study titled "Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants". This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab without berahyaluronidase alfa. The purpose of this study is to assess t...
What is the current status of trial NCT07646548?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-06-11. Estimated completion is 2026-09-30.
What interventions are being tested in trial NCT07646548?
The interventions under investigation include: Dupilumab (BIOLOGICAL), Dupilumab coformulated with berahyaluronidase alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT07646548?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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