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

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
Sanofi
Study ID
NCT05976360
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 2, 2014
Status verified
Jul 2023
Primary completion
Jan 17, 2015
Completion
Jan 17, 2015

Study Design

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

Arms

  • Active Comparator: Dupilumab drug product 1
    A single subcutaneous injection on Day 1
  • Experimental: Dupilumab drug product 2
    A single subcutaneous injection on Day 1

Primary Outcome Measure

Maximum serum concentration observed: Cmax [ Time Frame: Up to Day 57 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Prism Research-Site Number:840002Saint PaulMinnesota55144-
Biokinetic Clinical Applications-Site Number:840003SpringfieldMissouri65802-

Find similar trials in Saint Paul, MN

By research site
Prism Research· Saint Paul, MNBiokinetic Clinical Applications· Springfield, MO

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