Health TrialsbyHealthPanel

A Study of LY4178256 in Healthy Participants

ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to check how much LY4178256 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 7 months and will include either 7 or 12 visits depending on the assigned treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4178256

    Drug

    Administered intravenously (IV)

  • Placebo

    Drug

    Administered IV

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b)Experimental treatment 2 interventions
Group B: LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module

Time frame
Screening to Day 169
2

Part B: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module

Time frame
Screening to Day 197

Secondary outcomes

1

Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256

To evaluate PK after a single dose of LY4178256

Time frame
Predose up to Day 8
2

Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256

To evaluate PK after multiple doses \[LC14.1\]of LY4178256

Time frame
Predose up to Day 64

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: