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

NCT ID: NCT05976373

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-05
• Study Completion Date: 2015-03-30

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.

Conditions

Healthy Volunteers

Study Design

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

Study Groups

Dupilumab drug product 1

A single subcutaneous injection on Day 1

Group Type: ACTIVE_COMPARATOR

Dupilumab (SAR231893)

Intervention Type: DRUG

injection solution subcutaneous

Dupilumab drug product 2

A single subcutaneous injection on Day 1

Group Type: EXPERIMENTAL

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 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.

• 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

Prism Research-Site Number:840001

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

U1111-1290-9387

Identifier Type: REGISTRY

Identifier Source: secondary_id

PKM14271

Identifier Type: -

Identifier Source: org_study_id