HealthyPhase 1NCT07276958
A Study of LY4298445 in Healthy Participants and Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
A Phase 1 study testing LY4298445 in people with Healthy and Systemic Lupus Erythematosus, run by Eli Lilly and Company at 10 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- What is being tested?
- LY4298445
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 4 Feb 2026to Mar 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants between the ages of 18 and 55 years.
- Have body weight of at least 50 kilograms (kg) and body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m²), inclusive.
- Participants with Systemic Lupus Erythematosus (SLE)
- Are 18 to 75 years of age, inclusive.
- Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg/m², inclusive.
- Have a clinical diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria at least 6 months prior to screening.
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- Participants with Rheumatoid Arthritis (RA)
- Are 18 to 75 years of age, inclusive.
- Have body weight between 45 and 145 kg, inclusive, and BMI between 18 and 35 kg/m², inclusive.
- Have a diagnosis of adult-onset RA for at least 6 months prior to screening, as defined by the 2010 ACR/EULAR classification criteria
- Have Disease Activity Score in 28 joints (DAS28)-high-sensitivity C-reactive protein (hsCRP) greater than or equal to 3.2.
- Have positive test results for rheumatoid factor or anti-citrullinated peptide antibodies
- Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 2 advanced therapies (biological disease-modifying antirheumatic drug [bDMARD] or targeted synthetic DMARD [tsDMARD]) after failing a conventional synthetic DMARD (csDMARD).
Who cannot join
- Have known allergies to LY4298445, related compounds, or any components of the formulation
- Are individuals assigned female at birth (AFAB) who are lactating or have a positive pregnancy test at screening or Day -1.
- Have severe active lupus-associated renal disease (lupus nephritis) defined clinically and/or by
- urine protein/creatinine ratio greater than 200 milligrams per millimole (mg/mmol) (as an estimate of approximate proteinuria greater than 2 reams (g) per day) or
- an estimated glomerular filtration rate (eGFR) less than 40 milliliters per minute (mL/min)/1.73 m² at screening, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021.
- requiring hemodialysis within 6 months prior to screening
- Have active central nervous system lupus as defined by ACR nomenclature for neuropsychiatric lupus syndromes and as captured by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K); seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, and cerebrovascular accident, within 2 months prior to screening
- Have a Class 4 RA according to the ACR revised criteria
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) contact
Physicians interested in becoming principal investigators please contact contact
10 sites in 3 countries
China7 sites, 7 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing, 100034
010-83572211
Zhuoli Zhang
- Not yet recruiting
Peking University Third Hospital
Beijing, 100191
010-82266699
Rong MU
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, 410008
0731-89753999
Hui LUO
- Not yet recruiting
Anhui Provincial Hospital
Hefei, 230036
0551-62284920
Zhu CHEN
- Not yet recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127
021-58752345
Shuang YE
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
0577-55578035
Li SUN
- Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
027-85726114
Qiubai LI
Australia2 sites, 2 recruiting
- Recruiting
Nucleus Network
Brisbane, 4006
+617 3707 2720
Gloria Wong
- Recruiting
Nucleus Network
Melbourne, VIC 3004
+61 1800 243 733
Christina Catherine Chang
Japan1 site, 1 recruiting
- Not yet recruiting
Clinical Research Hospital Tokyo
Shinjuku-ku, 160-0004
81120023812
Hiroyuki Fukase
About this study
Official title: A Phase 1, Multicenter, Randomized, Placebo-Controlled, Participant-Blind, Single-Ascending Dose Study of LY4298445 in Healthy Participants and an Open-Label Single-Ascending Dose and Multiple-Ascending Dose Study of LY4298445 in Participants With Systemic Lupus Erythematosus or Rheumatoid Arthritis
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.
- Conditions
- Healthy, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- Being tested
- LY4298445
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4298445Drug
Administered SC
LY4298445Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4298445 (Part A1) | Experimental | Single-ascending dose (SAD) of LY4298445 administered subcutaneously (SC) or intravenously (IV) in healthy participants Receives: Drug: LY4298445 |
| LY4298445 Placebo (Part A1) | Placebo comparator | SAD of LY4298445 administered SC or IV in healthy participants Receives: Drug: LY4298445 |
| LY4298445 (Part A2) | Experimental | SAD of LY4298445 administered SC in participants with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA) Receives: Drug: LY4298445 |
| LY4298445 (Part B) | Experimental | Multiple-ascending doses (MAD) of LY4298445 administered SC in participants with SLE or RA Receives: Drug: LY4298445 |
| LY4298445 (Part C) | Experimental | Single dose of LY4298445 administered SC in healthy Japanese and, optionally, Chinese participants Receives: Drug: LY4298445 |
| LY4298445 Placebo (Part C) | Placebo comparator | Single dose of LY4298445 administered SC in healthy Japanese and, optionally, Chinese participants Receives: Drug: LY4298445 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline up to Week 52
Secondary outcomes (3)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4298445
PK: AUC of LY4298445
Measured: Baseline up to Approximately Week 57
PK: Maximum Concentration (Cmax) of LY4298445
PK: Cmax of LY4298445
Measured: Baseline up to Week 52
Pharmacodynamic (PD): Degree of Peripheral B Cell Depletion Following Biopsy in Participants
PD: Peripheral B cell depletion
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start4 Feb 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276958
- Sponsor's protocol ID
- 27747
- Other IDs
- J6S-MC-KCAA, 2026-527207-25-00
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No