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OpenTrials
Completed

NCT Number: NCT06395012

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

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.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel ACT, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

LY3985297

Drug

Administered either IV or SC.

Placebo

Drug

Administered either IV or SC.

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

    Time frame: Baseline up to Week 13 (Part A), Week 17 (Part B)

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module

Secondary outcomes

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

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

  2. PK: Cmax of LY3985297 following subcutaneous (SC) administration

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

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

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

  4. PK: AUC of LY3985297 following SC administration

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

  5. Bioavailability (%F) of LY3985297 following SC administration

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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 LY3985297 in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 1, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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