A Study of LY4355756 in Healthy Participants
- Summary
- The purpose of the study is to assess how LY4355756 is absorbed by the body and how safe it is to healthy participants. There will be four inpatient stays at the clinical research unit (CRU). For Part A there will be 5 continuous days, Part B 22 continuous days, Part C 5 continuous days in each of the 3 periods, and Part D 18 continuous days in the CRU.
- Short title
- A Study of LY4355756 in Healthy Participants
- Official title
- A Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY4355756 in Healthy Participants
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-01-01
- First posted
- 2026-08-14
- Registry last updated
- 2026-10-08
- Primary completion date
- 2027-01-01
- Start date
- 2026-08-17
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07765498
- ClinicalTrials.gov ID
- NCT07765498
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- Double masking
- Masking description
- Parts A and B are Double-Blinded, Parts C and D are Open-Label
- Masked roles
- Participants, Investigators
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Timeframe: Baseline up to the Safety Follow up Visit (6 months)
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
Timeframe: Baseline up to the Safety Follow up Visit (6 months)
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY4355756
Timeframe: Baseline up to Day 18
PK: Maximum Plasma Concentration (Cmax) of LY4355756
Timeframe: Baseline up to Day 18
PK: AUC of Midazolam
Timeframe: Baseline up to Day 14
PK: Cmax of Midazolam
Timeframe: Baseline up to Day 14
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
-
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
-
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
- Fortrea Clinical Research UnitDallas, United StatesRecruiting
Other registry identifiers
- J6U-MC-KZAA