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OpenTrials
Completed

NCT Number: NCT05565729

A Phase I Study 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.

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Dallas

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3471851

Drug

Administered SC.

Other names: NKTR-358

Placebo

Drug

Administered SC.

Levocetirizine

Drug

Administered orally.

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851

    Time frame: Predose up to 56 days postdose

    PK: Cmax of LY3471851

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

    Time frame: Predose up to 56 days postdose

    PK: AUC of LY3471851

Sponsors and collaborators

Lead sponsor

Nektar Therapeutics

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2022
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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