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Monoclonal Antibodies

LY3839840 for Healthy Participants

Phase 1
Recruiting
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 up to 14 days post dose
Awards & highlights

Study Summary

This trial tests if a new drug is safe and how it is processed in the body when given in different amounts.

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.Check my eligibility
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.See study design
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
Select...
I am a man who agrees to use contraception, or I am a woman who cannot become pregnant.
Select...
My heart health and lab tests are within normal ranges.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,487 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,633 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has LY3839840 (Part A) been granted official sanction from the FDA?

"Considering that this is a Phase 1 trial, which does not possess ample evidence of safety or efficacy, our team at Power assigned LY3839840 (Part A) a score of 1."

Answered by AI

Who qualifies to become a participant in this investigation?

"The criteria for enrolment into this trial necessitates that participants should be physically robust and aged between 18 and 65. In total, 112 people will be accepted to the study."

Answered by AI

Are participants of this experiment limited to a certain age range?

"To be considered for this research project, subjects must fall within the age range of 18 and 65 years old."

Answered by AI

Are there still available positions in this research program?

"According to the details provided on clinicaltrials.gov, this study is not currently recruiting patients. This trial was first posted on December 4th 2023 and the last update was made November 23rd of that same year. Nevertheless, there are 808 other clinical trials looking for subjects as we converse."

Answered by AI

Who else is applying?

What site did they apply to?
CenExel ACT
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

To make some side money.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A First-In-Human Study of LY3839840 in Healthy Participants
2023. "A First-In-Human Study of LY3839840 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153355.
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~19 spots leftby Jun 2024
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