Study of Ixekizumab in Healthy Participants

Part of paid clinical trials in Dallas, Texas.

Sponsor
Eli Lilly and Company
Study ID
NCT03848403
Phase
PHASE1
Status
Terminated

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 the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions \[ISRs\]) will be collected.

Key Dates

Start date
Jan 29, 2019
Status verified
Nov 2022
Primary completion
Jul 18, 2019
Completion
Jul 18, 2019

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Injection Pain Visual Analog Scale (VAS) Score [ Time Frame: Day 1, 8, and 15: Immediately (within 1 minute) after injection ]

Locations (2)

FacilityCityStateZIPSite coordinators
CovanceDallasTexas75247-4989-
Covance Clinical Research IncMadisonWisconsin53704-

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