A Study of LY3478006 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3478006 in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04230122
• Other study ID #: 17458
• Secondary ID: J2F-MC-OHAA
• Status: Terminated
• Phase: Phase 1
• Start date: February 17, 2020
• Est. completion date: June 4, 2020

Study information

• Verified date: November 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn more about how safe and how well tolerated LY3478006 is when given by injection into a vein or just under the skin to healthy participants. Blood tests will be done to check how much LY3478006 is in the bloodstream and how long the body takes to get rid of it. For each participant, the study will last up to about 16 weeks, including screening.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 4, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Are overtly healthy male or female Japanese or non-Japanese participants, as determined by medical history and physical examination
• Women not of childbearing potential
• Are aged 18 to 55 years (20 to 55 years for Japanese participants), inclusive, at screening

Exclusion Criteria:

• Have clinically significant abnormal electrocardiogram (ECG) results
• Have persistent abnormal blood pressure or pulse rate, as determined by the investigator
• Have evidence of orthostatic hypotension, defined as a decrease in systolic or diastolic blood pressure greater than or equal to (=)20 millimeters of mercury (mmHg) or =10 mmHg, respectively
• Have significant history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders
• Have a history or presence of mononeuropathy, polyneuropathy, or autonomic neuropathy
• Have significant allergies to humanized monoclonal antibodies

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3478006 - IV
Administered IV
• LY3478006 - SC
Administered SC
• Placebo - IV
Administered IV
• Placebo - SC
Administered SC

Locations

Country	Name	City	State
United States	Covance	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

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	Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.	Baseline through study completion (up to 109 days)
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006	Cmax of LY3478006 was evaluated.	Predose; Day 1 with end of infusion, 3, 6, 12 hours
Secondary	PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-8) of LY3478006	AUC0-8 of LY3478006 was evaluated. The unit of measure is hour*microgram per milliliter (hr*mcg/mL).	Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85