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Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT05976386
Collaborator
Regeneron Pharmaceuticals (Industry)
182
Enrollment
1
Location
2
Arms
3.5
Actual Duration (Months)
51.3
Patients Per Site Per Month

Study Details

Study Description

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 current dupilumab product in male and female healthy participants aged 18 to 65 years.

The estimated duration is up to 21 days of screening period, followed by the treatment day with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total duration from screening to EOS will be 64 days maximum.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dupilumab (SAR231893)
 Phase 1

Detailed Description

Duration per participant is up to 64 days

Study Design

Study Type:
Interventional
Actual Enrollment :
182 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Parallel Design, Single Dose Study to Compare the Pharmacokinetics of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
Actual Study Start Date :
Jun 8, 2021
Actual Primary Completion Date :
Sep 24, 2021
Actual Study Completion Date :
Sep 24, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: New dupilumab product

A single subcutaneous injection on Day 1

Drug: Dupilumab (SAR231893)
Injection solution Subcutaneous
Other Names:
  • REGN668

    		•
    Active Comparator: Current dupilumab product

    A single subcutaneous injection on Day 1

    Drug: Dupilumab (SAR231893)
    Injection solution Subcutaneous
    Other Names:
  • REGN668

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum serum concentration of functional dupilumab (Cmax) [Pre-dose on Day 1 up to Day 43]

    2. Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast) [Pre-dose on Day 1 up to Day 43]

    Secondary Outcome Measures

    1. Incidence of treatment-emergent adverse events (TEAEs) [Day 1 up to Day 43]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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 Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Pharmacology of Miami-Site Number:8400001 Miami Florida United States 33014

    Sponsors and Collaborators

    • Sanofi
    • Regeneron Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT05976386
    Other Study ID Numbers:
    • PKM17324
    • U1111-1266-7002
    First Posted:
    Aug 4, 2023
    Last Update Posted:
    Aug 4, 2023
    Last Verified:
    Jul 9, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes

    Study Results

    No Results Posted as of Aug 4, 2023