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A Study to Investigate the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT05976360
Collaborator
Regeneron Pharmaceuticals (Industry)
38
Enrollment
2
Locations
2
Arms
2.5
Actual Duration (Months)
19
Patients Per Site
7.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of 2 different dupilumab drug product in healthy volunteers. The duration per participant is up to 11 weeks.

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

Detailed Description

Duration per participant is up to 11 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Parallel Design Study of the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products After Administration of Single Subcutaneous Doses
Actual Study Start Date :
Nov 2, 2014
Actual Primary Completion Date :
Jan 17, 2015
Actual Study Completion Date :
Jan 17, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dupilumab drug product 1

A single subcutaneous injection on Day 1

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

    		•
    Experimental: Dupilumab drug product 2

    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 observed: Cmax [Up to Day 57]

    2. Time to reach Cmax (tmax) [Up to Day 57]

    3. Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast) [Up to Day 57]

    Secondary Outcome Measures

    1. Incidence of treatment-emergent adverse events (TEAEs) [Up to Day 57]

    2. Incidence of anti-dupilumab antibodies (ADA) [Up to Day 57]

    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.

    • Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).

    • Body weight between 70.0 and 90.0 kg, inclusive.

    • Having given written informed consent prior to undertaking any study-related procedure.

    Exclusion Criteria:

    • Any history or 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 (more than twice a month).

    • Blood donation or collection totaling more than 250 mL (including collections during study screening) within 2 months before inclusion on Day -1.

    • Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.

    • History of light-headedness or syncope during blood collection or injection of medications.

    • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.

    • History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).

    • If female, pregnancy (defined as positive β-human chorionic gonadotropin blood test) or breast-feeding.

    • Any history or 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.

    • Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or 5 elimination half-lives of the respective investigational drug, whichever is longer, of the inclusion visit.

    • Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

    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 Prism Research-Site Number:840002 Saint Paul Minnesota United States 55144
    2 Biokinetic Clinical Applications-Site Number:840003 Springfield Missouri United States 65802

    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:
    NCT05976360
    Other Study ID Numbers:
    • PKM14161
    • U1111-1290-9436
    First Posted:
    Aug 4, 2023
    Last Update Posted:
    Aug 4, 2023
    Last Verified:
    Jul 24, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Additional relevant MeSH terms:
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Aug 4, 2023