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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Dupilumab (SAR231893); Drug: Dupilumab (SAR231893)

Detailed Description

Duration per participant is up to 11 weeks.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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; Drug: Dupilumab (SAR231893); Injection solution, subcutaneous.; Other Names: REGN668

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum serum concentration observed: Cmax	Up to Day 57
Time to reach Cmax (tmax)	Up to Day 57
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

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Up to Day 57
Incidence of anti-dupilumab antibodies (ADA)	Up to Day 57

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2014
• Primary Completion (Actual): January 17, 2015
• Study Completion (Actual): January 17, 2015

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 24, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: PKM14161; U1111-1290-9436 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes