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A Study of LY3090106 in Japanese and Caucasian Healthy Participants

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY3090106
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03736772
I6M-JE-SSAA (Other Identifier)
14828

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety of a study drug known as LY3090106 in healthy Caucasian and Japanese participants. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug. The study will last about 12 weeks, not including screening or additional follow-up.

Enrollment

30 patients

Sex

All

Ages

20 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Overtly healthy Japanese or Caucasian
  • Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)

Exclusion criteria

  • Have participated, within the last 30 days, in a clinical study involving an investigational product (IP). If the previous IP has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed
  • Have had symptomatic herpes zoster within 3 months of screening
  • Show evidence of active or latent tuberculosis (TB)
  • Have known hypogammaglobulinemia or a screening serum immunoglobulin (Ig) G <565 milligrams per deciliter (mg/dL)
  • Have received live or attenuated vaccine(s) within 1 month of screening, or intend to during the study
  • Are immunocompromised
  • Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. Participants with any prior exposure to ixekizumab, tabalumab or other biologic agents directly targeting Interleukin 17 (IL-17) and/or B cells (e.g., rituximab, belimumab, etc.) are excluded

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

LY3090106
Experimental group
Description:
LY3090106 administered subcutaneously (SC)
Treatment:
Drug: LY3090106
Placebo
Placebo Comparator group
Description:
Placebo administered SC
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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