A Study of Ixekizumab in Healthy Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT03848416
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 three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1 and Test 2) have not been approved. This study will compare how much of each of the three formulations get into the blood stream. Information about any side effects that may occur will also be collected.

Key Dates

Start date
Jan 29, 2019
Status verified
Jan 2020
Primary completion
Jun 7, 2019
Completion
Jun 7, 2019

Study Design

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

Arms

  • Experimental: Ixekizumab (Reference)
    Reference formulation ixekizumab 80 milligram (mg) administered as a subcutaneous (SC) injection in a prefilled syringe.
  • Experimental: Ixekizumab (Test 1)
    Test 1 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.
  • Experimental: Ixekizumab (Test 2)
    Test 2 formulation ixekizumab 80 mg administered as an SC injection in a prefilled syringe.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ixekizumab [ Time Frame: Predose, Day 3, Day 5, Day 11, Day 15, Day 22, Day 29, Day 36, Day 43, Day 57, Day 71 and Day 85 Post Dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance Clinical Research IncDaytona BeachFlorida32117-

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Covance Clinical Research Inc· Daytona Beach, FL

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