Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Galderma R&D
Study ID
NCT05405985
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Nemolizumab — DRUG
    Nemolizumab with Auto-Injector (AI).
  • Nemolizumab — DRUG
    Nemolizumab with Dual-Chamber Syringe (DCS).

Study Details

This study was to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors \[AI\] (test) versus dual-chamber syringes \[DCS\] (reference) under controlled conditions in healthy adult subjects.

Key Dates

Start date
Aug 11, 2022
Status verified
Nov 2024
Primary completion
Nov 11, 2022
Completion
Dec 8, 2022

Study Design

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

Arms

  • Experimental: Nemolizumab With Auto-Injector (AI)
    Participants received a 60 milligrams (mg) dose of nemolizumab as 2 successive subcutaneous (SC) injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 centimeters \[cm\]) apart with AI on Day 0 (injection day).
  • Experimental: Nemolizumab With Dual Chamber Syringe (DCS)
    Participants received a 60-mg dose of nemolizumab as 2 successive subcutaneous injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Nemolizumab [ Time Frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose ]

Locations (2)

FacilityCityStateZIPSite coordinators
Galderma Investigational Site 7024TempeArizona85283-
Galderma Investigational Site 7023LincolnNebraska68502-

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Galderma Investigational· Tempe, AZGalderma Investigational· Lincoln, NE

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