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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: Recruiting Phase 1 study, sponsored by Sanofi.
NCT07646548 is a Phase 1 study that is actively recruiting participants, run by Sanofi. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax: Maximum concentration observed in serum
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 |
What NCT07646548 shows while recruiting
NCT07646548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Dupilumab is the first listed.
NCT07646548 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07646548's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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