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

NCT ID: NCT05976386

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2021-09-24

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.

Detailed Description

Duration per participant is up to 64 days

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

New dupilumab product

A single subcutaneous injection on Day 1

Group Type: EXPERIMENTAL

Dupilumab (SAR231893)

Intervention Type: DRUG

Injection solution Subcutaneous

Current dupilumab product

A single subcutaneous injection on Day 1

Group Type: ACTIVE_COMPARATOR

Dupilumab (SAR231893)

Intervention Type: DRUG

Injection solution Subcutaneous

Interventions

Dupilumab (SAR231893)

Injection solution Subcutaneous

Intervention Type: DRUG

Other Intervention Names

REGN668

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Pharmacology of Miami-Site Number:8400001

Miami, Florida, United States

Countries

United States

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25328&tenant=MT_SNY_9011

PKM17324 Plain Language Results Summary

Other Identifiers

U1111-1266-7002

Identifier Type: REGISTRY

Identifier Source: secondary_id

PKM17324

Identifier Type: -

Identifier Source: org_study_id