- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07545590
A Study of Eltrekibart (LY3041658) in Healthy Participants
April 16, 2026 updated by: Eli Lilly and Company
A Phase 1, Open-Label, Single Dose Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Formulations of Eltrekibart in Healthy Participants
The main purpose of this study is to evaluate how eltrekibart is absorbed by the body when it is given under the skin to healthy participants.
The study will last about 17 weeks.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: LillyTrials@Lilly.com
Study Contact Backup
- Name: Physicians interested in becoming principal investigators please contact
- Email: clinical_inquiry_hub@lilly.com
Study Locations
-
-
-
Singapore, Singapore, 138623
- Lilly Centre for Clinical Pharmacology
-
Principal Investigator:
- Greg Li
-
Contact:
- Phone Number: +65 6413 9838
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Are overtly healthy as determined by medical evaluation including medical history and physical examination
- Have a minimum body weight of 45 kilograms (kg).
- Have a body mass index (BMI) within the range of 18.5 to 28.5 kilograms per square meter (kg/m²), inclusive
Exclusion Criteria:
- Have multiple severe allergies to prescription or nonprescription drugs
- Are immunocompromised
Have had any of the following types of infection within 3 months prior to the screening visit:
- Serious, that is, requiring hospitalization, or intravenous or equivalent oral antibiotic treatment
- Opportunistic infections Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over
- Chronic, that is, duration of symptoms, signs, or treatment of 6 weeks or longer, or
Recurring, including, but not limited to:
- herpes simplex,
- herpes zoster,
- recurring cellulitis, or
- chronic osteomyelitis.
- Are currently pregnant or are intending to become pregnant or to breastfeed at any time in the study or within 16 weeks after receiving the single dose of study intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eltrekibart Cohort 1
Eltrekibart administered subcutaneously (SC)
|
Administered SC
Other Names:
Administered IV
Other Names:
|
|
Experimental: Eltrekibart Cohort 2
Eltrekibart administered SC
|
Administered SC
Other Names:
Administered IV
Other Names:
|
|
Experimental: Eltrekibart Cohort 3
Eltrekibart administered intravenously (IV)
|
Administered SC
Other Names:
Administered IV
Other Names:
|
|
Experimental: Eltrekibart Cohort 4
Eltrekibart administered SC
|
Administered SC
Other Names:
Administered IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
Time Frame: Predose on Day 1 up to Day 85
|
Predose on Day 1 up to Day 85
|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3041658
Time Frame: Predose on Day 1 up to Day 85
|
Predose on Day 1 up to Day 85
|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration AUC(0-tlast) of LY3041658
Time Frame: Predose on Day 1 up to Day 85
|
Predose on Day 1 up to Day 85
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: 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), Eli Lilly and Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
April 16, 2026
First Submitted That Met QC Criteria
April 16, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
April 16, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 27485
- I7P-MC-DSAI (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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