A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Sponsor
Eli Lilly and Company
Study ID
NCT03073213
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ixekizumab — DRUG
    Administered as subcutaneous (SC) injection

Study Details

The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.

Key Dates

Start date
Apr 13, 2017
Status verified
Jun 2019
Primary completion
May 14, 2019
Completion
May 14, 2019

Study Design

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

Arms

  • Experimental: Ixekizumab single dose
    Participants received single dose of 80mg Ixekizumab by subcutaneous injection.
  • Experimental: Ixekizumab Multiple Regimen 1 (80mg Q2W)
    Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
  • Experimental: Ixekizumab Multiple Regimen 2 (80mg Q4W)
    Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.

Primary Outcome Measure

Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) [ Time Frame: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141 ]

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