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

A Single-Dose, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3090106 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01925157

Enrollment

Registered

2013-08-19

Start date

2013-08-31

Completion date

2015-09-30

Last updated

2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

BIOLOGICALLY3090106 - SQ

Administered SQ.

BIOLOGICALLY3090106 - IV

Administered IV.

BIOLOGICALPlacebo - SQ

Administered SQ.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

for Healthy Participants: * Males or non-pregnant females age 18 to 65 years * Body Mass Index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2) Inclusion Criteria for Participants for RA: * Diagnosis of at least mildly active adult-onset RA * Positive anti-citrullinated protein (ACPA) antibodies or rheumatoid factor * Regular use of MTX for at least 12 weeks and at a stable dose (10 to 25 mg/week) for at least 4 weeks prior to baseline * American College of Rheumatology (ACR) Functional Class I, II or III

Exclusion criteria

for Healthy Participants: * Have received biologic agents within 3 months or 5 half-lives * Have surgery within 12 weeks prior to screening * Known history of human immunodeficiency virus (HIV infection and/or positive human HIV antibodies) * Have evidence of, or test positive for, hepatitis C virus or hepatitis B virus * Have evidence of active infection or fever * Have donated greater than 500 mL blood within 30 days prior to screening * Smoke greater than 10 cigarettes/day or equivalent * Have received live vaccine within 1 month of screening * Have a history of allergy to monoclonal antibodies or severe drug allergies

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Bulgaria, Moldova, Poland, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026