Evaluating LY4005130 in healthy individuals

A Phase 1, Randomized, Placebo-controlled, Investigator and Participant Blinded, Single-ascending Dose and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4005130 in Healthy Participants.

This study is testing a new drug called LY4005130 in healthy people to see if it is safe and how well their bodies handle it.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Eli Lilly and Company (industry)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06690996 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of LY4005130 in healthy participants. It involves administering the drug either subcutaneously or intravenously and monitoring its absorption and elimination through blood tests. The study is divided into two parts: single-ascending doses and multiple-ascending doses, with a total duration of approximately 12 to 20 weeks depending on the part. Participants will have multiple visits for evaluations throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are healthy adults with a body weight of at least 45 kg and a BMI greater than 18.

Not a fit: Patients with underlying health conditions or those not meeting the specific eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety profile of LY4005130, which may inform future treatments.

How similar studies have performed: While this study focuses on a specific drug, similar studies evaluating the safety of new compounds in healthy participants have shown success in the past.

Eligibility criteria

Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead (electrocardiogram) ECG. If any values are outside the normal range and considered to be significant, for example, elevated white blood cell count, the respective test may be repeated once at the discretion of the investigator without consultation with the sponsor
* If enrolled as Japanese or Chinese, the entry requirements are as follows:

  * To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan
  * To qualify as Chinese for the purpose of this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
* Have a body weight 45 kilogram (kg) or greater and body mass index greater than 18 and less than 32 kilogram per square meter (kg/m²)

Exclusion Criteria:

* Are an individual of childbearing potential (IOCBP)
* Have known allergies to LY4005130, related compounds, or any components of the formulation
* Have received a live vaccine within 28 days of screening or intend to do so during the study or within 28 days after the study

  * Non-live or inactivated vaccinations are allowed
  * Bacillus Calmette Guerin vaccine must not have been administered within 12 months before screening
* Had a surgical procedure within 12 weeks before screening;

  * during the study, or
  * within 28 days after the study
* Have a history of allergy to medications that could be used to treat infusion reactions, or to the drug excipients
* Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, significant history of atopy, or a history of severe posttreatment hypersensitivity reactions. These reactions include, but are not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis
* Have a diagnosis or history of malignant disease within 5 years prior to screening, with the following exceptions

  * Basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
  * Cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to screening
* Have had breast cancer within the past 10 years
* Have a history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection that, in the opinion of the sponsor or investigator, poses an unacceptable risk to the participant
* Have a current or recent acute, active infection

Where this trial is running

Dallas, Texas

• Fortrea Clinical Research Unit — Dallas, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Conditions: Healthy