Clinical trial NCT03148431: A Study of LY3002815 in Healthy Participants
Official title: A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3002815 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-05-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purposes of this study are to determine:

* The safety of the study drug and any side effects that might be associated with it.
* How much of the study drug gets into the blood stream and how long it takes the body to remove it in healthy participants.

Participants will be admitted to the Clinical Research Unit (CRU) for 3 overnight stays.

This study involves a single dose of LY3002815 or placebo given as an injection into the vein. This study will last approximately 16 weeks including screening. Additional follow-up may be required.

This study is for research purposes only, and is not intended to treat any medical condition.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination. Males will be required to use reliable method of birth control. Females have to be of non-child-bearing potential
* Have a body mass index (BMI) of 18 to 32 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion Criteria:

* Have family history of early onset Alzheimer's Disease (AD)
* Have impaired cognitive function
* Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
* Have significant allergic reactions to LY3002815, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
* Women who are lactating
* Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results

Primary outcomes:
measure: 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 through at least 85 days after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3002815
timeFrame: Baseline through at least 85 days after administration of study drug
measure: Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3002815
timeFrame: Baseline through at least 85 days after administration of study drug
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
state: UK
Study officials:
affiliation: Eli Lilly and Company
name: Call 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)
role: STUDY_DIRECTOR
References: