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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Dupilumab (SAR231893)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05976360

PKM14161

U1111-1290-9436 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Duration per participant is up to 11 weeks.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Dupilumab drug product 1

Active Comparator group

Description:

A single subcutaneous injection on Day 1

Treatment:

Drug: Dupilumab (SAR231893)

Drug: Dupilumab (SAR231893)

Dupilumab drug product 2

Experimental group

Description:

A single subcutaneous injection on Day 1

Treatment:

Drug: Dupilumab (SAR231893)

Drug: Dupilumab (SAR231893)