A Study of LY3090106 in Japanese and Caucasian Healthy Participants

NCT03736772 | Completed Phase 1 FDA Drug

• 2 other identifiers: 14828I6M-JE-SSAA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum Observed Drug Concentration (Cmax) of LY3090106

  Baseline through Day 85

• Area Under the Concentration-Versus-Time Curve (AUC) of LY3090106

  Baseline through Day 85

Study Arms (2)

LY3090106

EXPERIMENTAL

LY3090106 administered subcutaneously (SC)

Drug: LY3090106

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY3090106 DRUG

Administered SC

LY3090106

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 9, 2018
• Study Start: November 19, 2018
• Primary Completion: March 13, 2019
• Study Completion: March 13, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)