A Study to Investigate the Pharmacokinetics (PK), 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
NCT05976373
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 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.

Key Dates

Start date
Jan 5, 2015
Status verified
Jul 2023
Primary completion
Mar 30, 2015
Completion
Mar 30, 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 of functional dupilumab (Cmax) [ Time Frame: Pre-dose on Day 1 up to Day 57 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Prism Research-Site Number:840001Saint PaulMinnesota55144-

Find similar trials in Saint Paul, MN

By research site
Prism Research· Saint Paul, MN

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