Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults

Part of paid clinical trials in Miami, Florida.

Sponsor
Sanofi
Study ID
NCT05976386
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in male and female healthy participants aged 18 to 65 years. The estimated duration is up to 21 days of screening period, followed by the treatment day with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total duration from screening to EOS will be 64 days maximum.

Key Dates

First listed
Aug 4, 2023
Start date
Jun 8, 2021
Status verified
Sep 2025
Primary completion
Sep 24, 2021
Completion
Sep 24, 2021

Study Design

Enrollment
182 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: New dupilumab product
    A single subcutaneous injection on Day 1
  • Active Comparator: Current dupilumab product
    A single subcutaneous injection on Day 1

Primary Outcome Measure

Maximum serum concentration of functional dupilumab (Cmax) [ Time Frame: Pre-dose on Day 1 up to Day 43 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of Miami-Site Number:8400001MiamiFlorida33014-

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By research site
Clinical Pharmacology of Miami· Miami, FL

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