Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
Recruiting
Phase 1
Interventional Study
Healthy Volunteers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 40 (estimated)
- Sponsor
- Sanofi · Industry
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About This Trial
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 berahyalu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male and/or female participant, between 18 and 60 years of age, inclusive, at the time of signing the informed consent.
* Determined to be healthy by the Investigator using a comprehensive clinical assessment (detailed medical history and complete physical examination).
* Body…
Contacts
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
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