Status:
COMPLETED
Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Duration per participant is up to 64 days
Eligibility Criteria
Inclusion
- Male or female participants, between 18 and 65 years of age, inclusive.
- Body weight between 65.0 and 95.0 kg, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Having given written informed consent prior to undertaking any study-related procedure.
Exclusion
- Presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- Presence or history of drug or biologic hypersensitivity, or allergic disease diagnosed and treated by a physician (excluding seasonal allergy).
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- Smoking regularly and unable to stop smoking during the inpatient portion of the study (occasional smoker can be enrolled).
- If female, pregnancy (defined as positive β-human chorionic gonadotropin (HCG) blood test) or breastfeeding.
- Any biologics (antibody or its derivatives) given within 4 months before inclusion or within 5 half-lives (whichever takes longer).
- Participation in any previous clinical trial of dupilumab.
- Participation in any clinical research study evaluating another investigational drug or therapy in which the inclusion visit for the current study will be within 30 days of receiving the drug or 5 elimination half-lives (whichever is longer).
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2021
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT05976386
Start Date
June 8 2021
End Date
September 24 2021
Last Update
September 19 2025
Active Locations (1)
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1
Clinical Pharmacology of Miami-Site Number:8400001
Miami, Florida, United States, 33014