What side effects are associated with this type of intervention?

In first-in-human studies of new drugs like LY3839840, common side effects observed in healthy participants often include mild-to-moderate adverse events such as headaches, dizziness, nausea, and injection site reactions. These side effects are typically transient and manageable. For treatments similar to LY3839840, which may involve monoclonal antibodies or other novel therapeutic agents, additional side effects could include nasopharyngitis, erythema, and mild gastrointestinal symptoms. Serious adverse events are rare but can occur, emphasizing the importance of close monitoring during clinical trials.

What prior FDA approvals exist?

Prior FDA approvals for treatments in healthy subjects often involve early-phase clinical trials that assess the safety and pharmacokinetics of new investigational drugs. These studies typically include single and multiple dose administrations to evaluate how the drug is processed in the body and to identify any potential adverse effects. This approach is similar to the study of LY3839840, which is being investigated for its safety and pharmacokinetics in healthy participants.

What other types of research exist?

Promising alternatives to LY3839840 include HLX02, MYL-1401O, and IRDye800CW-nimotuzumab. HLX02 and MYL-1401O have demonstrated comparable safety profiles and pharmacokinetic bioequivalence to trastuzumab in clinical trials. IRDye800CW-nimotuzumab has shown safety and lack of common toxicities in preclinical studies.

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Monoclonal Antibodies

LY3839840 for Healthy Participants

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).

Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study.

Must not have

Have a significant history of or current rheumatologic, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome, hyperthyroidism, hyperaldosteronism), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data.

Have had any significant infections within 3 months prior to the screening visit, or develop any of these infections before the randomization visit.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose on day 1 up to 14 days post dose

Summary

This trial tests a new drug called LY3839840 to see if it is safe for humans. Participants will receive varying doses of the drug. Researchers will observe how the drug is processed in the body.

Who is the study for?

This trial is for healthy adults with good venous access for blood sampling. Specific parts require first-generation Chinese or Japanese descent, as defined by the participant's ancestry. Participants must have a BMI of >18 to ≤35 kg/m² (18-29 kg/m² for certain parts), normal vital signs and lab results, agree to contraceptive requirements, and not be pregnant.

What is being tested?

The study tests LY3839840 against a placebo in healthy individuals to assess its safety at various doses and understand how it's processed by the body. It involves giving single and multiple doses of LY3839840 or a placebo.

What are the potential side effects?

As this is a first-in-human study, specific side effects of LY3839840 are unknown but may include typical drug-related reactions such as allergies, gastrointestinal issues, fatigue, headaches or other responses that will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man who agrees to use contraception, or I am a woman who cannot become pregnant.

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My heart health and lab tests are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major health issues that could affect drug processing or pose risks with new medications.

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I have not had any serious infections in the last 3 months.

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I have signs of active or latent tuberculosis.

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I haven't donated more than 450 mL of blood or participated in a study requiring over 400 mL of blood donation in the last 4 months.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose on day 1 up to 14 days post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose on day 1 up to 14 days post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 up to 14 days post dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

Secondary study objectives

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3839840

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3839840

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3839840 (Part D)Experimental Treatment1 Intervention

Multiple ascending dose of LY3839840 administered orally in Japanese participants.

Group II: LY3839840 (Part C)Experimental Treatment1 Intervention

Single and multiple dose of LY3839840 administered orally in Chinese participants.

Group III: LY3839840 (Part B)Experimental Treatment1 Intervention

Multiple ascending dose of LY3839840 administered orally.

Group IV: LY3839840 (Part A)Experimental Treatment1 Intervention

Single ascending dose of LY3839840 administered orally.

Group V: PlaceboPlacebo Group1 Intervention

Placebo administered orally.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

In first-in-human studies like the one investigating LY3839840, the primary focus is on understanding the safety and pharmacokinetics of the drug. These studies often involve administering single and multiple doses to healthy subjects to observe how the drug is absorbed, distributed, metabolized, and excreted. The mechanisms of action for such investigational drugs typically involve targeting specific biological pathways or receptors to achieve a desired therapeutic effect. For healthy subjects, this matters because it helps establish a safety profile and optimal dosing regimen before the drug is tested in patients with specific conditions. Ensuring the drug is safe and well-tolerated in healthy individuals is a critical first step in the drug development process.

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