A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

Conditions

• Healthy
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• LY4298445 — DRUG
  Administered SC
• LY4298445 — DRUG
  Administered IV

Study Details

The purpose of this study is to investigate the safety and tolerability of LY4298445 in healthy participants and in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participation in the study will last up to approximately 52 weeks.

Key Dates

First listed

Dec 11, 2025

Start date

Feb 4, 2026

Status verified

Jul 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

63 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: LY4298445 (Part A1)
  Single-ascending dose (SAD) of LY4298445 administered subcutaneously (SC) or intravenously (IV) in healthy participants
• Placebo Comparator: LY4298445 Placebo (Part A1)
  SAD of LY4298445 administered SC or IV in healthy participants
• Experimental: LY4298445 (Part A2)
  SAD of LY4298445 administered SC in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA)
• Experimental: LY4298445 (Part B)
  Multiple-ascending doses (MAD) of LY4298445 administered SC in participants with SLE or RA
• Experimental: LY4298445 (Part C)
  Single dose of LY4298445 administered SC in healthy Japanese and Chinese participants
• Placebo Comparator: LY4298445 Placebo (Part C)
  Single dose of LY4298445 administered SC in healthy Japanese and Chinese participants

Primary Outcome Measure

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to Week 52 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559)
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

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