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

NCT05976386 | Completed Phase 1 FDA Drug

• 2 other identifiers: PKM17324U1111-1266-7002
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Maximum serum concentration of functional dupilumab (Cmax)

  Pre-dose on Day 1 up to Day 43

• 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 Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  Day 1 up to Day 43

Study Arms (2)

New dupilumab product

EXPERIMENTAL

A single subcutaneous injection on Day 1

Drug: Dupilumab (SAR231893)

Current dupilumab product

ACTIVE COMPARATOR

A single subcutaneous injection on Day 1

Drug: Dupilumab (SAR231893)

Interventions

Dupilumab (SAR231893) DRUG

Injection solution Subcutaneous

Also known as: REGN668

Current dupilumab product; New dupilumab product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• Participation in any previous clinical trial of dupilumab.
• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Clinical Pharmacology of Miami-Site Number:8400001

Miami, Florida, 33014, United States

Location

Related Links

• PKM17324 Plain Language Results Summary

MeSH Terms

Interventions

dupilumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: June 8, 2021
• Primary Completion: September 24, 2021
• Study Completion: September 24, 2021
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)