NCT04998487

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2021

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 16, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2022

Completed
Last Updated

November 18, 2023

Status Verified

November 15, 2023

Enrollment Period

11 months

First QC Date

August 9, 2021

Last Update Submit

November 15, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851

    PK: Cmax of LY3471851

    Predose up to 56 days postdose

  • PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851

    PK: AUC of LY3471851

    Predose up to 56 days postdose

Study Arms (2)

LY3471851 (Abdomen)

EXPERIMENTAL

LY3471851 administered subcutaneously (SC) into the abdomen.

Drug: LY3471851

LY3471851 (Thigh)

EXPERIMENTAL

LY3471851 administered SC into the thigh.

Drug: LY3471851

Interventions

LY3471851DRUG

Administered SC.

LY3471851 (Abdomen)LY3471851 (Thigh)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LabCorp CRU, Inc.

Daytona Beach, Florida, 32117, United States

Location

Study Officials

  • Study Director

    Nektar Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 10, 2021

Study Start

August 16, 2021

Primary Completion

July 6, 2022

Study Completion

July 6, 2022

Last Updated

November 18, 2023

Record last verified: 2023-11-15

Data Sharing

IPD Sharing
Will not share

Locations

US(1)