A Phase I Study of LY3471851 in Healthy Participants

November 15, 2023 updated by: Nektar Therapeutics

A Phase 1, Randomized, Placebo-controlled, Participant- and Investigator-blind, Single-dose Study of the Pharmacokinetics of LY3471851 Following Subcutaneous Dosing of LY3471851 in Healthy Participants

The purpose of this study is to compare two different formulations (test & reference) of LY3471851 in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving the study drug that is LY3471851.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Covance Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants who are overtly healthy as determined by medical history and physical examination
  • Have body weight greater than 45 kilograms (kg) and body mass index within the range 18.0 to 32.0 kilograms per square meter (kg/m²)
  • Male and female participants must agree to adhere to contraceptive requirements

Exclusion Criteria:

  • Have an abnormality in the 12-lead electrocardiogram (ECG), vital signs, or both
  • Have had symptomatic herpes zoster within 3 months prior to screening
  • Have a known allergy or hypersensitivity to levocetirizine
  • Intend to use prescription or nonprescription medication within 14 days or 5 half-lives prior to dosing
  • Have received treatment with biologic agents within 3 months or 5 half-lives prior to dosing
  • Smoke more than 10 cigarettes or other tobacco products per day before study entry
  • Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC.
Experimental: LY3471851 (Test formulation)
LY3471851 administered subcutaneously (SC).
Drug: LY3471851
Administered SC.
Other Names:
  • NKTR-358
Experimental: LY3471851 (Test) + Levocetirizine
LY3471851 administered SC in combination with levocetirizine given orally.
Drug: LY3471851
Administered SC.
Other Names:
  • NKTR-358
Drug: Levocetirizine
Administered orally.
Active Comparator: LY3471851 (Reference formulation)
LY3471851 administered SC.
Drug: LY3471851
Administered SC.
Other Names:
  • NKTR-358

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851
Time Frame: Predose up to 56 days postdose
PK: Cmax of LY3471851
Predose up to 56 days postdose
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851
Time Frame: Predose up to 56 days postdose
PK: AUC of LY3471851
Predose up to 56 days postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nektar Therapeutics

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Study Director, Nektar Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2022

Primary Completion (Actual)

February 23, 2023

Study Completion (Actual)

February 23, 2023

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 2, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17603
  • J1P-MC-KFAN (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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