ACTIVE_NOT_RECRUITING

A Study of LY4005130 in Healthy Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4005130 gets into the bloodstream and how long it takes the body to eliminate it. Part A for the single-ascending doses (SAD) of the study will last about 12 weeks with 9 visits. Part B for the multiple-ascending doses (MAD) of the study will either last about 16 weeks with 13 visits or 26 weeks with 14 visits not including screening.

Official Title

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.

Quick Facts

Study Start:2024-11-08

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06690996

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Fortrea Clinical Research Unit

Dallas, Texas, 75247

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

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

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 Registration Dates

Study Start Date2024-11-08

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-11-08

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Healthy