A Study of LY3090106 in Japanese and Caucasian Healthy Participants

NCT ID: NCT03736772

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2019-03-13

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3090106

LY3090106 administered subcutaneously (SC)

Group Type EXPERIMENTAL

LY3090106

Intervention Type DRUG

Administered SC

Placebo

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3090106

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Countries

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United States

Other Identifiers

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I6M-JE-SSAA

Identifier Type: OTHER

Identifier Source: secondary_id

14828

Identifier Type: -

Identifier Source: org_study_id

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