Clinical Pharmacology of Miami- Site Number : 8400001
Hialeah, Florida, 33014, United States
NCT Number: NCT07646548
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.
This study is active but is not currently recruiting participants.
18 year–60 year
All sexes
Interventional
Phase 1
Hialeah, Florida, 33014, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Other names: SAR231893, Dupixent
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Other names: SAR231893, Dupixent
Time frame: From Day 1 to Day 85 (end of study)
Cmax: Maximum concentration observed in serum
Time frame: From Day 1 to Day 85 (end of study)
AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Time frame: From Day -1 to Day 85.
Time frame: On Day 1, Day 43 and Day 85
Sanofi
Industry
Phase 1, Single Center, Open-label, Randomized, Parallel-group Study to Evaluate Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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