A Study of LY3002815 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3002815 in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03148431
• Other study ID #: 16529
• Secondary ID: I9G-MC-CCBA2016-
• Status: Terminated
• Phase: Phase 1
• Start date: May 24, 2017
• Est. completion date: September 26, 2018

Study information

• Verified date: October 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 26, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3002815
Administered IV
• Placebo
Administered IV

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3002815		Baseline through at least 85 days after administration of study drug
Secondary	Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-8]) of LY3002815		Baseline through at least 85 days after administration of study drug