Clinical trial NCT05976373: A Study to Investigate the Pharmacokinetics (PK), Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2023-08-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetic of 2 different dupilumab drug products in adult healthy volunteers. The duration per participant is up to 11 weeks.

Detailed description: Duration per participant is up to 11 weeks.

Eligibility criteria: Inclusion Criteria:

* Male or female participants, between 18 and 65 years of age, inclusive.
* Body weight between 70.0 and 90.0 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:

* 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 (HCG) blood test) or breast-feeding.
* 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.

Primary outcomes:
measure: Maximum serum concentration of functional dupilumab (Cmax)
timeFrame: Pre-dose on Day 1 up to Day 57
measure: Time to reach Cmax (Tmax)
timeFrame: Pre-dose on Day 1 up to Day 57
measure: Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)
timeFrame: Pre-dose on Day 1 up to Day 57
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Day 1 up to Day 57
measure: Incidence of anti-dupilumab antibodies (ADA)
timeFrame: Day 1 up to Day 57
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Prism Research-Site Number:840001
state: Minnesota
Study officials:
References: