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NCT Number: NCT07046559

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy Participants

The main purpose of this study is to explore the safety and any side effects of LY4066708 in healthy participants. The study will also measure how much LY4066708 gets into the bloodstream and the central nervous system and how long it takes the body to remove it. The study will last up to 24 weeks for each participant.

Recruiting

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Holbeck, Leeds, LS11 9EH, United Kingdom

Location status: Recruiting

Location contact

Firas Almazedi

PRINCIPAL_INVESTIGATOR

CONTACT

1-866-429-3700

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • Japanese Participants Only: To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
  • Chinese Participants Only: To qualify as Chinese for the purpose of this study, all 4 of the participants' biological grandparents must be of exclusive Chinese descent and born in China, Hong Kong, Macau, or Taiwan.
  • Have a body mass index (BMI) at the time of screening within the range 18.5 to 30 kilogram per meter squared (kg/m²) (inclusive).
  • Participants assigned female at birth (AFAB) not of childbearing potential and participants assigned male at birth (AMAB) willing to practice effective contraception throughout the study may participate.
  • Willingness to undergo study procedures which may include repeated lumbar punctures

Exclusion criteria

  • Are individuals of childbearing potential (IOCBP). Notwithstanding their IOCBP status, participants AFAB are excluded if they are breastfeeding.
  • A history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome).
  • The use of concomitant medications that prolong the QT/QTc interval.
  • Have known allergies to LY4066708 or any components of the formulation, or history of allergic reactions to any transferrin receptor (TfR) antibodies.
  • Have participated, within the 3 months of screening, in a clinical trial involving a study intervention (other than the study intervention used in this study). If the previous investigational product has a long half-life (t½), 3 months or 5 half-lives (whichever is longer) should have passed.
  • Are persons who have previously completed or withdrawn from this study and have previously received the study intervention. This exclusion criterion does not apply to subjects who are allowed to rescreen prior to randomization.
  • 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, or may confound ECG data analysis.
  • Show evidence of hepatitis C and/or positive hepatitis C antibody.
  • Current infection with hepatitis B virus (HBV) or evidence of past infection with HBV, that is, positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core total antibody (anti-HBc).
  • A marked baseline prolongation of time from the start of the Q wave to the end of the T wave/ corrected QT interval (QT/QTc) interval (for example, repeated demonstration of a corrected time from the start of the Q wave to the end of the T wave interval - Fridericia formula (QTcF) interval greater than 450 ms).

Treatment and study plan

LY4066708

Drug

Administered IV

Placebo

Drug

Administered IV

Primary outcomes

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

    Time frame: Baseline up to Week 12

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

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

    Time frame: Screening to Day 22

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

Secondary outcomes

  1. Part A: Pharmacokinetics (PK)- Area Under the Plasma Concentration Versus Time Curve (AUC0-168)

    Time frame: Predose up to day 15

    To evaluate PK after a single dose of LY4066708

  2. Part B: Pharmacokinetics (PK)- AUC0-168

    Time frame: Day 1 up to day 7

    To evaluate PK after multiple doses of LY4066708

  3. Part A: Pharmacokinetics (PK)- Maximum Observed Drug Concentration (Cmax)

    Time frame: Predose up to day 15

    To evaluate PK after a single dose of LY4066708

  4. Part B: Pharmacokinetics (PK)- Cmax

    Time frame: After dose 3, up to day 64

    To evaluate PK after a single dose of LY4066708

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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