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OpenTrials
Completed

NCT Number: NCT05976373

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Prism Research-Site Number:840001

Saint Paul, Minnesota, 55144, United States

About this study

Duration per participant is up to 11 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab (SAR231893)

Drug

injection solution subcutaneous

Other names: REGN668

Primary outcomes

  1. Maximum serum concentration of functional dupilumab (Cmax)

    Time frame: Pre-dose on Day 1 up to Day 57

  2. Time to reach Cmax (Tmax)

    Time frame: Pre-dose on Day 1 up to Day 57

  3. Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)

    Time frame: Pre-dose on Day 1 up to Day 57

Secondary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Day 1 up to Day 57

  2. Incidence of anti-dupilumab antibodies (ADA)

    Time frame: Day 1 up to Day 57

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 4, 2023
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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