A Study of LY3848575 in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics With Single Intravenous Ascending Doses and Single and Multiple Subcutaneous Doses of LY3848575 in Healthy Participants, Including First-generation Japanese Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05727072
• Other study ID #: 18589
• Secondary ID: J4F-MC-CYAA
• Status: Completed
• Phase: Phase 1
• Start date: February 10, 2023
• Est. completion date: February 19, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3848575 when administered either intravenously or subcutaneously in single ascending or multiple doses in healthy non-Japanese and first generation Japanese participants. The study will also assess how fast LY3848575 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 142 days excluding the screening period of 28 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 19, 2024
• Est. primary completion date: February 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation

• Have body weight of at least 50 kilograms (kg) for males and 40 kg for females, and body mass index of 18 to 30 kilograms per meter squared (kg/m²), inclusive

• For cohorts with Japanese participants: To qualify as a participant of the 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

Exclusion Criteria:

• Are currently enrolled in any other clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.

• Have participated, within the last 3 months, in a clinical study involving an IP.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3848575
Administered IV.
• LY3848575
Administered SC.
• Placebo
Administered IV.
• Placebo
Administered SC.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of TEAEs, SAEs and Other Non-serious Adverse Events (AEs), Regardless of causality, will be reported in the Reported Adverse Events module	Baseline through 142 days
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3848575 When Administered IV.	PK: AUC of LY3848575 When Administered IV.	End of infusion through day 85
Secondary	PK: AUC of LY3848575 When Administered SC.	PK: AUC of LY3848575 When Administered SC.	Predose through day 85