A Phase I Study of LY3471851 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-05

Study Completion Date

2023-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

NCT00653224

Seasonal Allergic Rhinitis

COMPLETED PHASE4

A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis

NCT00621959

Seasonal Allergic Rhinitis

COMPLETED PHASE4

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

NCT00521131

Rhinitis Allergic Perennial

COMPLETED PHASE4

A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)

NCT06339008

Perennial Allergic Rhinitis (PAR)

RECRUITING PHASE3

Evaluation of Safety of Levocetirizine in Routine Clinical Practice-non- Interventional Study

NCT00598780

Rhinitis Allergic, Persistent

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY3471851 (Test formulation)

LY3471851 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3471851

Intervention Type DRUG

Administered SC.

LY3471851 (Test) + Levocetirizine

LY3471851 administered SC in combination with levocetirizine given orally.

Group Type EXPERIMENTAL

LY3471851

Intervention Type DRUG

Administered SC.

Levocetirizine

Intervention Type DRUG

Administered orally.

LY3471851 (Reference formulation)

LY3471851 administered SC.

Group Type ACTIVE_COMPARATOR

LY3471851

Intervention Type DRUG

Administered SC.

Placebo

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY3471851

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

Levocetirizine

Administered orally.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NKTR-358

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes