A first-in-human test of LY4355756 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, interventional study in healthy volunteers to examine pharmacokinetics and safety of LY4355756. It uses four inpatient CRU stays with multiple parts to assess absorption and tolerability, including parts lasting 5, 22, and 18 days. The study also administers Midazolam as a reference or comparator, under close monitoring. Eligibility requires healthy status, BMI 18.0–32.0, and appropriate birth-assigned sex with contraception per local regulations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, electrocardiogram (ECGs), and vital signs
* Have a body mass index within the range 18.0-32.0 kilograms per square meter (kg/m²) (inclusive)
* Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB)

  * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria:

* Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders, or abnormal laboratory values at screening
* Have an abnormality in 12-lead ECG at screening that, in the opinion of the investigator, may increase the risk associated with participating in the study or may confound ECG data analysis
* Have a diagnosis or history of malignancy within 5 years prior to screening

  * Exceptions:

    * basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
    * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to screening
* Have had breast cancer within the past 10 years
* Have a history or presence of multiple or severe allergies, or an anaphylactic reaction, to prescription or nonprescription drugs or food
* Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization visit, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment
* Have a current infection with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
* Have received any live (including attenuated live vaccines), non-live, or inactivated vaccine(s) within less than 4 weeks before randomization or intend to receive them during the study
* Are individuals AFAB who, during the study, are pregnant, have positive pregnancy testing, intend to become pregnant, are lactating, or intend to breastfeed

Where it's running

• Fortrea Clinical Research Unit
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.