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

Lilly

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: LY3985297

Study type: Interventional

Funder types: Industry

Identifiers

NCT06395012

18794

J4S-MC-KSAA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 153 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

153 participants in 3 patient groups, including a placebo group

Part A: LY3985297 (Cohorts 1-8)

Experimental group

Description:

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

Treatment:

Drug: LY3985297

Part B: LY3985297 (Cohorts 1-4)

Experimental group

Description:

Multiple ascending dose of LY3985297 administered either IV or SC.

Treatment:

Drug: LY3985297

Placebo Comparator: Part A and B: Placebo

Placebo Comparator group

Description:

Placebo administered either IV or SC.

Treatment:

Drug: Placebo