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- Klinische proef NCT07646548
Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
Phase 1, Single Center, Open-label, Randomized, Parallel-group Study to Evaluate Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab without berahyaluronidase alfa.
The purpose of this study is to assess the pharmacokinetic (PK) characteristics of a single SC dose of dupilumab coformulated with berahyaluronidase alfa and dupilumab without berahyaluronidase alfa in healthy participants aged ≥18 and ≤60 years.
Study details include:
- The study duration will be approximately up to 12 to 15 weeks.
- The treatment will be administered as a single dose on Day 1.
- The number of visits will be 14.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Florida
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Hialeah, Florida, Verenigde Staten, 33014
- Clinical Pharmacology of Miami- Site Number : 8400001
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Male and/or female participant, between 18 and 60 years of age, inclusive, at the time of signing the informed consent.
- Determined to be healthy by the Investigator using a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Body weight between 50.0 and 100.0 kg, inclusive.
- BMI between 18.0 and 32.0 kg/m2 (inclusive).
Exclusion Criteria:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological, 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 (for vomiting only: more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP of ≥30 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, or clinically significant allergic disease as diagnosed and treated by a physician. Participants with known hypersensitivity to any of the study interventions, or components thereof.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- Regular smoking of more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking during the study (occasional smoker can be enrolled).
- Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
- If female, pregnancy (defined as positive urine pregnancy test); breast-feeding.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Treatment A
Participants will receive a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa on Day 1
|
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Andere namen:
|
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Experimenteel: Treatment B
Participants will receive a SC dose of dupilumab without berahyaluronidase alfa on Day 1
|
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab
Tijdsspanne: From Day 1 to Day 85 (end of study)
|
Cmax: Maximum concentration observed in serum
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From Day 1 to Day 85 (end of study)
|
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PK parameter in serum: AUClast of dupilumab
Tijdsspanne: From Day 1 to Day 85 (end of study)
|
AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast
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From Day 1 to Day 85 (end of study)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, injection site reactions and clinically significant laboratory values and vital signs
Tijdsspanne: From Day -1 to Day 85.
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From Day -1 to Day 85.
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Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa
Tijdsspanne: On Day 1, Day 43 and Day 85
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On Day 1, Day 43 and Day 85
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Angel Lamas, MD, Clinical Pharmacology of Miami (CPMI)
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PKM20425
- U1111-1331-0702 (Register-ID: ICTRP)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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