A First-In-Human Study of LY3985297 in Healthy Participants

NCT06395012 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18794J4S-MC-KSAA
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to see if LY3985297, the study drug, is safe and well-tolerated when given as a single dose or as multiple doses either through an intravenous (into a vein) or a subcutaneous (under the skin) injection in healthy participants. Study will also evaluate how much of the study drug LY3985297 gets into the blood stream and how long it takes the body to remove it. The study is conducted in two parts (part A and B), each part has a separate treatment cohort. The study will last up to approximately 116 days for part A, and 145 days for part B, including the screening period.

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 up to Week 13 (Part A), Week 17 (Part B)

Secondary Outcomes (5)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3985297 following intravenous (IV) administration

  Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)

• PK: Cmax of LY3985297 following subcutaneous (SC) administration

  Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985297 following IV administration

  Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)

• PK: AUC of LY3985297 following SC administration

  Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)

• Bioavailability (%F) of LY3985297 following SC administration

  Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)

Study Arms (3)

Part A: LY3985297 (Cohorts 1-8)

EXPERIMENTAL

Single ascending dose of LY3985297 administered either intravenously (IV) or subcutaneously (SC). Cohort 5,6 and 7 is conducted in Japanese or Chinese participants.

Drug: LY3985297

Part B: LY3985297 (Cohorts 1-4)

EXPERIMENTAL

Multiple ascending dose of LY3985297 administered either IV or SC.

Drug: LY3985297

Placebo Comparator: Part A and B: Placebo

PLACEBO COMPARATOR

Placebo administered either IV or SC.

Drug: Placebo

Interventions

LY3985297 DRUG

Administered either IV or SC.

Part A: LY3985297 (Cohorts 1-8); Part B: LY3985297 (Cohorts 1-4)

Placebo DRUG

Administered either IV or SC.

Placebo Comparator: Part A and B: Placebo

Eligibility Criteria

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

You may qualify if:

• Participants must be overtly healthy, as determined by medical evaluation.
• Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, and a minimum body weight of 45.0 kg.
• Participants must be assigned male or female at birth and not of childbearing potential.
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), clinical laboratory test results that are acceptable for the study.
• Have venous access sufficient to allow for blood sampling.
• For Part A Cohorts 5, 6, and 7:
• Participants must be first-generation Japanese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. Or
• Participants must be first-generation Chinese only, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Chinese descent and born in China.

You may not qualify if:

• Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization visit (Day 1).
• Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening or intend to during the study.
• Have a history of multiple or severe allergies, or an anaphylactic reaction, to prescription or nonprescription drugs or food.
• Show evidence of active or latent tuberculosis (TB).
• Have one of the following infections: hepatitis B, C virus or human immunodeficiency virus (HIV).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

CenExel ACT

Anaheim, California, 92801, United States

Location

ICON

Salt Lake City, Utah, 84124, 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: April 29, 2024
• First Posted: May 1, 2024
• Study Start: June 7, 2024
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)