A Study of LY3090106 in Japanese and Caucasian Healthy Participants

Healthy Clinical Trial

Official title:

A Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3090106 in Japanese and Caucasian Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736772
• Other study ID #: 14828
• Secondary ID: I6M-JE-SSAA
• Status: Completed
• Phase: Phase 1
• Start date: November 19, 2018
• Est. completion date: March 13, 2019

Study information

• Verified date: May 1, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3090106
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 85
Secondary	Maximum Observed Drug Concentration (Cmax) of LY3090106	Cmax of LY3090106	Baseline through Day 85
Secondary	Area Under the Concentration-Versus-Time Curve (AUC) of LY3090106	AUC of LY3090106	Baseline through Day 85