Clinical trial NCT06395012: A First-In-Human Study of LY3985297 in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: Baseline up to Week 13 (Part A), Week 17 (Part B)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3985297 following intravenous (IV) administration
timeFrame: Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
measure: PK: Cmax of LY3985297 following subcutaneous (SC) administration
timeFrame: Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985297 following IV administration
timeFrame: Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
measure: PK: AUC of LY3985297 following SC administration
timeFrame: Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
measure: Bioavailability (%F) of LY3985297 following SC administration
timeFrame: Predose on day 1 up to Week 13 (Part A), Week 17 (Part B)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: CenExel ACT
state: California
city: Salt Lake City
country: United States
facility: ICON
state: Utah
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: