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A Phase I Study of LY3471851 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05565729
Collaborator
Nektar Therapeutics (Industry)
42
Enrollment
1
Location
4
Arms
4.1
Anticipated Duration (Months)
10.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Oct 5, 2022
Anticipated Primary Completion Date :
Feb 7, 2023
Anticipated Study Completion Date :
Feb 7, 2023

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    Placebo Comparator: Placebo

    Placebo administered SC.

    Drug: Placebo
    Administered SC.

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851 [Predose up to 56 days postdose]

      PK: Cmax of LY3471851

    2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851 [Predose up to 56 days postdose]

      PK: AUC of LY3471851

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Dallas Dallas Texas United States 75247

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Nektar Therapeutics

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05565729
    Other Study ID Numbers:
    • 17603
    • J1P-MC-KFAN
    First Posted:
    Oct 4, 2022
    Last Update Posted:
    Oct 20, 2022
    Last Verified:
    Oct 15, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    Interleukin-2
    NKTR-358
    Pharmacokinetics
    Additional relevant MeSH terms:
    Levocetirizine

    Study Results

    No Results Posted as of Oct 20, 2022