Status:
COMPLETED
A Study to Investigate the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
Duration per participant is up to 11 weeks.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05976360
Start Date
November 2 2014
End Date
January 17 2015
Last Update
August 4 2023
Active Locations (2)
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1
Prism Research-Site Number:840002
Saint Paul, Minnesota, United States, 55144
2
Biokinetic Clinical Applications-Site Number:840003
Springfield, Missouri, United States, 65802