150 Participants NeededMy employer runs this trial

LY4302814 for Healthy Subjects

Recruiting at 1 trial location
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Overseen ByPhysicians interested in becoming principal investigators please contact

What You Need to Know Before You Apply

What is the purpose of this trial?

This Phase 1 trial tests a new treatment called LY4302814 to evaluate its tolerance and potential side effects in healthy individuals. Participants will receive the treatment either intravenously (IV, through a vein) or subcutaneously (SC, under the skin), while some will receive a placebo for comparison. The trial aims to help researchers understand how the body processes the drug and its effects. It suits those who consider themselves healthy and are willing to stay overnight at the clinical research unit for a few days. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking any herbal, vitamin supplements, over-the-counter, or prescription medications at least 14 days before the trial and during the study, unless the investigator and sponsor decide it won't interfere with the study.

Is there any evidence suggesting that LY4302814 is likely to be safe for humans?

Research shows that LY4302814 is still under investigation to assess its tolerability. Limited information is available about the safety of this new drug. However, earlier studies with similar drugs have not shown any serious side effects.

For LY4302814 administered through an IV, no major side effects have been reported so far, but researchers continue to gather safety information. Similar treatments given as an injection under the skin have generally been well-tolerated, though detailed data for LY4302814 is not yet available.

This study is in the early stages, so safety remains the primary concern. While no serious safety issues have been identified, researchers will continue to monitor closely. Participants should be aware that the study aims to learn more about potential side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about LY4302814 because it offers a novel approach to treatment with its unique delivery methods and potential mechanism of action. Unlike standard treatments that may rely on oral administration, LY4302814 can be administered both intravenously (IV) and subcutaneously (SC), providing flexibility in how it can be delivered to patients. This could enhance patient comfort and compliance. Additionally, LY4302814 may target pathways differently than existing therapies, potentially offering new benefits or improved efficacy. These features make it a promising candidate for further development and study.

What evidence suggests that LY4302814 could be effective?

Research on LY4302814 remains in the early stages, so limited information exists on its efficacy. Scientists are examining its mechanism in the body and the body's response. In this trial, participants will receive either the intravenous (IV) form, the subcutaneous (SC) form of LY4302814, or a placebo. Studies often focus on the safety and effects of the IV form. The SC form, injected under the skin, may offer benefits like shorter treatment times and lower costs, similar to other drugs administered this way. Most current findings focus on safety and tolerability rather than effectiveness.24678

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy adults (21+ in Singapore) with a body weight of at least 45 kg and BMI between 18-32. Participants must not have significant health issues, infections like hepatitis or HIV, abnormal heart tests, high alcohol use, recent medication/supplement use, or smoke more than 5 cigarettes daily.

Inclusion Criteria

Are overtly healthy as determined by medical evaluation
Have clinical laboratory test results within the normal range for the population or investigative site or with abnormalities deemed not clinically significant by the investigator
My weight is at least 45 kg and my BMI is between 18 and 32.
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Exclusion Criteria

I have or had a serious medical condition.
Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator
Have a 12-lead electrocardiogram (ECG) abnormality, that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either LY4302814 or placebo, administered intravenously or subcutaneously. Blood tests are performed to assess pharmacokinetics and pharmacodynamics.

9 days
1 overnight stay in the clinical research unit

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • LY4302814

Trial Overview

The study is testing the safety and side effects of a new drug called LY4302814 compared to a placebo in healthy people. It involves blood tests and monitoring over about six months, including at least one overnight stay at the research center.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4302814 SCExperimental Treatment1 Intervention
Group II: LY4302814 IVExperimental Treatment1 Intervention
Group III: Placebo IVPlacebo Group1 Intervention
Group IV: Placebo SCPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

A Study of LY4302814 in Healthy Participants

The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/12377842/

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Material Safety Data Sheet

Additional Hazard Information: Short Term: May produce slight eye irritation, Active ingredient is not a skin irritant , Accidental ingestion.

Reference ID: 5482804 - accessdata.fda.gov

WARNING: HEPATOTOXICITY, CARDIOVASCULAR RISK, and. GASTROINTESTINAL RISK. See full prescribing information for complete boxed warning.