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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05976386
• Other study ID #: PKM17324
• Secondary ID: U1111-1266-7002
• Status: Completed
• Phase: Phase 1
• Start date: June 8, 2021
• Est. completion date: September 24, 2021

Study information

• Verified date: July 9, 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Duration per participant is up to 64 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Dupilumab (SAR231893)
Injection solution Subcutaneous

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami-Site Number:8400001	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum serum concentration of functional dupilumab (Cmax)		Pre-dose on Day 1 up to Day 43
Primary	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	Incidence of treatment-emergent adverse events (TEAEs)		Day 1 up to Day 43