A Phase I Study of LY3471851 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3471851
* Drug: Placebo
* Drug: Levocetirizine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3471851 (Test formulation)<br>LY3471851 administered subcutaneously (SC). | Drug: LY3471851<br>* Administered SC.<br>* Other names: NKTR-358;|
| Experimental: LY3471851 (Test) + Levocetirizine<br>LY3471851 administered SC in combination with levocetirizine given orally. | Drug: LY3471851<br>* Administered SC.<br>* Other names: NKTR-358;Drug: Levocetirizine<br>* Administered orally.<br>|
| Active Comparator: LY3471851 (Reference formulation)<br>LY3471851 administered SC. | Drug: LY3471851<br>* Administered SC.<br>* Other names: NKTR-358;|
| Placebo Comparator: Placebo<br>Placebo administered SC. | Drug: Placebo<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interleukin-2, NKTR-358, Pharmacokinetics