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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395012
• Other study ID #: 18794
• Secondary ID: J4S-MC-KSAA
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: May 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 153
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3985297
Administered either IV or SC.
• Placebo
Administered either IV or SC.

Locations

Country	Name	City	State
United States	CenExel ACT	Anaheim	California
United States	ICON	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	PK: Cmax of LY3985297 following subcutaneous (SC) administration		Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
Secondary	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)
Secondary	PK: AUC of LY3985297 following SC administration		Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
Secondary	Bioavailability (%F) of LY3985297 following SC administration		Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)