A Phase I Study of LY3471851 in Healthy Participants

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05565729

Enrollment

Registered

2022-10-04

Start date

2022-10-05

Completion date

2023-02-23

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Interleukin-2, NKTR-358, Pharmacokinetics

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.

Interventions

DRUGLevocetirizine

Administered orally.

DRUGLY3471851

Administered SC.

DRUGPlacebo

Administered SC.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026