A Study of LY3848575 in Healthy Participants

NCT05727072 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18589J4F-MC-CYAA
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3848575 When Administered IV.

  End of infusion through day 85

• PK: AUC of LY3848575 When Administered SC.

  Predose through day 85

Study Arms (4)

LY3848575 IV

EXPERIMENTAL

Single ascending doses of LY3848575 administered intravenously (IV).

Drug: LY3848575

Placebo IV

PLACEBO COMPARATOR

Placebo administered IV.

Drug: Placebo

LY3848575 SC

EXPERIMENTAL

Multiple doses of LY3848575 administered subcutaneously (SC).

Drug: LY3848575

Placebo SC

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3848575 DRUG

Administered IV.

LY3848575 IV

Placebo DRUG

Administered IV.

Placebo IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: February 14, 2023
• Study Start: February 10, 2023
• Primary Completion: February 19, 2024
• Study Completion: February 19, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)