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Recruiting NCT07090785

A Study of LY4088044 in Healthy Participants

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY4088044, LY4088044, Placebo, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, New Zealand, Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4088044 in Healthy Participants.

Overview

The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.

Interventions

  • Drug LY4088044
    Administered IV
  • Drug LY4088044
    Administered SC
  • Drug Placebo
    Administered IV
  • Drug Placebo
    Administered SC

Primary outcome measures

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Time frame: Baseline up to Approximately Day 190]
Secondary outcome measures (3)
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044 [Time frame: Baseline up to Approximately Day 190]
  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044 [Time frame: Baseline up to Approximately Day 190]
  • Pharmacodynamics (PD): Protein Levels in Skin Samples [Time frame: Baseline up to Approximately Day 190]

Eligibility criteria

Inclusion criteria

  • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring
  • Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²)

Exclusion criteria

  • Are individuals assigned female at birth (AFAB) who are pregnant and/or lactating
  • Regularly use known drugs of abuse or show positive findings on urinary drug screening that are not consistent with their medication history
  • Participants with hemoglobin outside of the local laboratory normal range for age and gender, or evidence of iron deficiency, or hemoglobinopathy
  • Participants with estimated glomerular filtration rate (GFR) less than 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m²)
  • Have a 12-lead electrocardiogram (ECG) abnormality
  • Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes AND are unable to abide by investigative site smoking restrictions
  • Have an average weekly alcohol intake that exceeds 21 units per week (males less than or equal to 65 years old) and 14 units per week (females and males over 65-year-old, if applicable) and are unwilling to abide by the restrictions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 4 centers
  • Collaborative Neuroscience Network - CNS — Los Alamitos
  • ICON — Lenexa
  • ICON Early Phase Services — San Antonio
  • ICON — Salt Lake City
New Zealand · 1 center
  • New Zealand Clinical Research Christchurch — Christchurch
Singapore · 1 center
  • Lilly Centre for Clinical Pharmacology — Singapore

Identifiers

NCT: NCT07090785 · 27275 · J5S-MC-CEAA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗