First-in-Human safety check for experimental drug LY4178256
NCT ID NCT07698210
First seen Jul 13, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This early-stage trial evaluates the safety and tolerability of a new drug called LY4178256 in healthy volunteers. Participants receive either the drug or a placebo intravenously, and researchers monitor side effects and how the body processes the drug. The study lasts about 7 months and includes up to 12 visits. Results will help determine if LY4178256 is safe enough to test in people with medical conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY4178256
- What this could lead to
- If safe and well-tolerated, this could pave the way for future studies of LY4178256 in people with specific diseases.
- What could go wrong
- This is an early phase 1 trial in only 88 healthy people, so results may not predict effects in patients. Side effects are unknown and being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, and other screening procedures. * Have a body mass index within the range of 19.0 to 32.0 kilograms per square meter (kg/m²) * Individuals assigned male at birth willing to practice effective contraception throughout the study and individuals assigned female at birth not of childbearing potential may participate in this trial. Exclusion Criteria: * Have significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the Investigational Medicinal Product (IMP); or of interfering with the interpretation of data. * Have abnormal blood pressure * Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, have a mean QT interval corrected using Fridericia's formula (QTcF) of greater than 450 milliseconds (\>450 msec) for males, or \>470 msec for females. * Regularly use known drugs of abuse or with positive drug results (within the past 3 months). * Have a positive ethanol breath/urine test result or positive urine drugs of abuse screen at screening or check-in. * Have hemoglobin level less than 12 grams per deciliter (\<12 g/dL), or evidence of iron deficiency (ferritin less than 30 nanograms per milliliter (\<30 ng/mL), or history or presence of hemoglobinopathy, or history hemolytic anemia. Participants who received transfusion within the past 12 weeks, or requiring regular transfusion should be excluded. * Have clinically significant abnormal liver function tests at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP), or total bilirubin ≥1.5x upper limit normal (ULN). Participants with confirmed Gilbert's syndrome may be enrolled. * Have significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per square meter (eGFR\<60mL/min/1.73 m ²)).
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Collaborative Neuroscience Network - CNS
NOT_YET_RECRUITINGLos Alamitos, California, 90720, United States
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ICON
RECRUITINGSalt Lake City, Utah, 84124, United States
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