Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate to different formulations of remternetug after single subcutaneous (SC) administration with either an autoinjector (AI) or a prefilled syringe (PFS). The study will look at the amount of remternetug that gets into the bloodstream and how long it takes the body to get rid of the remternetug when given as two different formulations. Participation in the study will last approximately 155 days.
Interventions
DRUGRemternetug (Test)
Administered SC
DRUGRemternetug (Reference)
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. * Have a body mass index within the range of 18.0 to 34.0 kilograms per meter squared (kg/m2) (inclusive).
Exclusion criteria
* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study drug or of interfering with the interpretation of data. * Have evidence of significant active neuropsychiatric disease, as determined by the investigator. * Have a personal or family history of early onset AD (AD diagnosed prior to 65 years of age). * Contraindication to MRI, including claustrophobia that cannot be managed with low-dose sedatives or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemakers. * Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, with the exception of vitamin/mineral supplements, any hormone replacement therapy, and/or thyroid replacement therapy, within 7 days prior to dosing and for the duration of the study. * Have a brain MRI that demonstrates any clinically significant findings that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK): Maximum Concentration (Cmax) of Remternetug | Predose up to Day 85 |
| Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve from Zero to time t [AUC(0-t)] of Remternetug | Predose up to Day 85 |
| Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity [AUC(0-inf)] of Remternetug | Predose up to Day 85 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK): Time of Maximum Concentration (tmax) of Remternetug | Predose up to Day 85 |
Countries
United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed