A Study of LY3002815 in Healthy Participants

NCT03148431 | Terminated Phase 1 FDA Drug

• 3 other identifiers: 16529I9G-MC-CCBA2016-004453-33
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  Baseline through at least 85 days after administration of study drug

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3002815

  Baseline through at least 85 days after administration of study drug

• Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3002815

  Baseline through at least 85 days after administration of study drug

Study Arms (2)

LY3002815

EXPERIMENTAL

Escalating doses of LY3002815 administered intravenously (IV) once in healthy participants

Drug: LY3002815

Placebo

PLACEBO COMPARATOR

Placebo administered IV once in healthy participants

Drug: Placebo

Interventions

LY3002815 DRUG

Administered IV

LY3002815

Placebo DRUG

Administered IV

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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.

Leeds, UK, United Kingdom

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: May 24, 2017
• Primary Completion: December 15, 2017
• Study Completion: September 26, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Locations

GB (1)