A First-In-Human Study of LY3985297 in Healthy Participants
- Registration Number
- NCT06395012
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 153
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: LY3985297 (Cohorts 1-8) LY3985297 Single ascending dose of LY3985297 administered either intravenously (IV) or subcutaneously (SC). Cohort 5,6 and 7 is conducted in Japanese or Chinese participants. Part B: LY3985297 (Cohorts 1-4) LY3985297 Multiple ascending dose of LY3985297 administered either IV or SC. Placebo Comparator: Part A and B: Placebo Placebo Placebo administered either IV or SC.
- Primary Outcome Measures
Name Time Method 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 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (2)
CenExel ACT
🇺🇸Anaheim, California, United States
ICON
🇺🇸Salt Lake City, Utah, United States