A Study of Two Formulations of Ixekizumab in Healthy Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT04259346
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to compare two different formulations of ixekizumab. One formulation (Reference) is approved by the Food and Drug Administration (FDA) and one formulation (Test) is not approved. This study will compare how much of each formulation gets into the blood stream. Information about any side effects that may occur will also be collected. The study will last up to about four months for each participant.

Key Dates

Start date
Feb 5, 2020
Status verified
Feb 2022
Primary completion
Feb 19, 2021
Completion
Feb 19, 2021

Study Design

Enrollment
245 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ixekizumab (Reference)
    Approved formulation of 80 milligram (mg) ixekizumab administered as a subcutaneous (SC) injection via autoinjector (AI).
  • Experimental: Ixekizumab (Test)
    Test formulation of 80 mg ixekizumab administered as a SC injection via AI.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab [ Time Frame: Predose, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 Post Dose ]

Locations (4)

FacilityCityStateZIPSite coordinators
Covance Clinical Research IncDaytona BeachFlorida32117-
Miami Research AssociatesMiamiFlorida33143-
Covance DallasDallasTexas75247-
Covance Clinical Research IncMadisonWisconsin53704-

Find similar trials in Daytona Beach, FL

By research site
Covance Clinical Research Inc· Daytona Beach, FLMiami Research Associates· Miami, FLCovance Dallas· Dallas, TXCovance Clinical Research Inc· Madison, WI

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