LY3985297 for Healthy Subjects

Recruiting at 1 trial location

Overseen By Ahad Sabet

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: Infections, Surgery, Allergies, Tuberculosis, others

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's likely that you should not be on any regular medications. Please check with the study team for specific guidance.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for healthy individuals who can participate in a study testing LY3985297. Specific eligibility details are not provided, but typically participants must meet certain health standards and have no conflicting medical conditions.

Inclusion Criteria

Participants must be overtly healthy, as determined by medical evaluation

Must have a body mass index of 18.0 to 32.0 kg/m², inclusive, and a minimum body weight of 45.0 kg

Must have venous access sufficient to allow for blood sampling

Exclusion Criteria

Must not have a history of multiple or severe allergies, or an anaphylactic reaction, to prescription or nonprescription drugs or food

I haven't had any major surgery in the last 12 weeks and don't plan to during the study.

I do not have active or latent tuberculosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single ascending dose of LY3985297 or placebo administered either intravenously (IV) or subcutaneously (SC)

12 weeks

Treatment Part B

Participants receive multiple ascending doses of LY3985297 or placebo administered either intravenously (IV) or subcutaneously (SC)

15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3985297 (Monoclonal Antibodies)

Trial Overview The trial tests the safety and tolerability of LY3985297 when given as a single or multiple doses via IV or subcutaneous injection to healthy people. It's split into two parts, assessing how the body absorbs and eliminates the drug.

Participant Groups

Group I: Part B: LY3985297 (Cohorts 1-4) Experimental Treatment 1 Intervention

Multiple ascending dose of LY3985297 administered either IV or SC.

Group II: Part A: LY3985297 (Cohorts 1-8) Experimental Treatment 1 Intervention

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

Group III: Placebo Comparator: Part A and B: Placebo Placebo Group 1 Intervention

Placebo administered either IV or SC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University