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A Study of LY3478006 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230122
Recruitment Status : Suspended (Protocol stopping criteria (safety) were met.)
First Posted : January 18, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3478006 - IV Drug: LY3478006 - SC Drug: Placebo - IV Drug: Placebo - SC Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3478006 in Healthy Subjects
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Arm Intervention/treatment
Experimental: LY3478006 - Intravenous (IV)
LY3478006 administered IV
Drug: LY3478006 - IV
Administered IV

Placebo Comparator: Placebo - IV
Placebo administered IV
Drug: Placebo - IV
Administered IV

Experimental: LY3478006 - Subcutaneous (SC)
LY3478006 administered SC
Drug: LY3478006 - SC
Administered SC

Placebo Comparator: Placebo - SC
Placebo administered SC
Drug: Placebo - SC
Administered SC




Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Day 85 ]
    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006 [ Time Frame: Predose on Day 1 through Day 85 ]
    PK: Cmax of LY3478006

  2. PK: Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC0-∞) of LY3478006 [ Time Frame: Predose on Day 1 through Day 85 ]
    PK: AUC0-∞ of LY3478006



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230122


Locations
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United States, Texas
Covance
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04230122    
Other Study ID Numbers: 17458
J2F-MC-OHAA ( Other Identifier: Eli Lilly and Company )
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No