A Single-Dose Study of LY3471851 in Healthy Participants

NCT ID: NCT04998487

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2022-07-06

Brief Summary

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The main purpose of this study is to estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it when administered under the skin in healthy participants. The study will also evaluate the safety and tolerability of LY3471851. The study is expected to last up to 87 days for each participant.

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

NONE

Study Groups

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LY3471851 (Abdomen)

LY3471851 administered subcutaneously (SC) into the abdomen.

Group Type EXPERIMENTAL

LY3471851

Intervention Type DRUG

Administered SC.

LY3471851 (Thigh)

LY3471851 administered SC into the thigh.

Group Type EXPERIMENTAL

LY3471851

Intervention Type DRUG

Administered SC.

Interventions

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LY3471851

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy males or females, as determined by medical history and physical examination.
* Body weight greater than 55 kilograms (kg) and body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²)

Exclusion Criteria

* Have evidence of clinically significant active infection, including fever 100.5ºF (38ºC) or above, within 28 days of dosing or Day 1 (before dosing)
* Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. Examples include but are not limited to infections requiring intravenous antibiotics, hospitalization, or prolonged treatment
* Are immunocompromised per investigator judgment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Nektar Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Nektar Therapeutics

Locations

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LabCorp CRU, Inc.

Daytona Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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J1P-MC-KFAL

Identifier Type: OTHER

Identifier Source: secondary_id

17604

Identifier Type: -

Identifier Source: org_study_id

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