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A Study of LY3478006 in Healthy Participants

NCT ID: NCT04230122

Last Updated: 2021-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-17

Study Completion Date

2020-06-04

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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10 milligram (mg) LY3478006 - Intravenous (IV)

Participants received single dose of 10 mg LY3478006 administered IV. Due to early termination of the study Cohort 2 to 6 (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg LY3478006 IV) were not explored for safety reasons following dosing of the first 4 participants in Cohort 1.

Group Type EXPERIMENTAL

LY3478006 - IV

Intervention Type DRUG

Administered IV

Placebo - IV

Participants received single dose of placebo administered IV. Placebo IV Cohorts 2 through 6 were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1.

Group Type PLACEBO_COMPARATOR

Placebo - IV

Intervention Type DRUG

Administered IV

100 mg LY3478006 - Subcutaneous (SC) (Cohort 7)

100 mg LY3478006 cohort 7 SC dose was not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1.

Group Type EXPERIMENTAL

LY3478006 - SC

Intervention Type DRUG

Administered SC

Placebo - SC (Cohort 7)

Placebo cohort 7 SC dose were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1.

Group Type PLACEBO_COMPARATOR

Placebo - SC

Intervention Type DRUG

Administered SC

Interventions

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LY3478006 - IV

Administered IV

Intervention Type DRUG

LY3478006 - SC

Administered SC

Intervention Type DRUG

Placebo - IV

Administered IV

Intervention Type DRUG

Placebo - SC

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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Covance

Dallas, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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J2F-MC-OHAA

Identifier Type: OTHER

Identifier Source: secondary_id

17458

Identifier Type: -

Identifier Source: org_study_id