A Study of LY3876602 in Healthy Participants

Healthy Clinical Trial

Official title:

A Randomised Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3876602 in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007638
• Other study ID #: 18734
• Secondary ID: J4K-MC-LALA2023-
• Status: Recruiting
• Phase: Phase 1
• Start date: August 23, 2023
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3876602 after administering as single ascending doses and following a data review proceeding to multiple ascending doses in healthy participants. The blood tests will also be performed to check how much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes the body to eliminate it.

The study will last up to approximately 17 weeks. A subgroup of participants will be consented for CSF collections.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male and female participants who are overtly healthy as determined by medical evaluation

• Have a body mass index with the range of 18 and less than or equal to (=) 32 kilograms per square meter (kg/m²)

• Male or female participants of nonchildbearing potential

Exclusion Criteria:

• Have a family history, defined as a parent or first-degree relative, of genetic neurodegenerative disorders

• Have allergies to diphenhydramine, epinephrine, or methylprednisolone

• Have serious or unstable medical conditions,

• History of skin wounding within 14 days of screening or current skin infection

• Are unwilling to stop alcohol consumption 48 hours prior to each dosing

• Have active or latent tuberculosis

• Participants in the cohorts undergoing lumbar puncture have an allergy to local anesthetics

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3876602
Administered IV.
• Placebo
Administered IV.

Locations

Country	Name	City	State
Netherlands	ICON Early Phase Services, LLC	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to 17 weeks
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602	PK: AUC of LY3876602	Predose up to 17 weeks
Secondary	PK: Maximum Observed Drug Concentration (Cmax) of LY3876602	PK: Cmax of LY3876602	Predose up to 17 weeks
Secondary	PK: Half-life (t1/2) of LY3876602	PK: t1/2 of LY3876602	Predose up to 17 weeks