A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: LY3090106 - SQ; Biological: Placebo - SQ; Biological: LY3090106 - IV

• Registration Number: NCT01925157
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the safety of the study drug known as LY3090106 in healthy participants and in participants with RA who are having an inadequate response to methotrexate (MTX). The study will investigate how the body processes the study drug and how the study drug affects the body. The study will last about 3 months for each participant.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Primary Completion: 2015-01
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3090106 (Healthy)	LY3090106 - SQ	Healthy participants will receive a single dose of LY3090106 in dose escalation cohorts subcutaneously (SQ).
Placebo (Healthy)	Placebo - SQ	Healthy participants will receive a single dose of placebo matching LY3090106 SQ.
Placebo (RA)	Placebo - SQ	Participants with RA will receive a single dose of placebo matching LY3090106 SQ.
LY3090106 (RA)	LY3090106 - SQ	Participants with RA will receive a single dose of LY3090106 in dose escalation cohorts SQ or intravenously (IV).
LY3090106 (RA)	LY3090106 - IV	Participants with RA will receive a single dose of LY3090106 in dose escalation cohorts SQ or intravenously (IV).

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration	Baseline through 12 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3090106	Predose through 12 Weeks
Number of Participants with Anti-LY3090106 Antibodies	Baseline through 12 Weeks
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3090106	Predose through 12 Weeks

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇷🇴 Bucharest, Romania