A Phase I Study of LY3471851 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3471851; Drug: Placebo; Drug: Levocetirizine

• Registration Number: NCT05565729
• Lead Sponsor: Nektar Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-04
• Study Start: 2022-10-05
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-23
• Status Verified: 2023-11-02
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3471851 (Test formulation)	LY3471851	LY3471851 administered subcutaneously (SC).
LY3471851 (Test) + Levocetirizine	LY3471851	LY3471851 administered SC in combination with levocetirizine given orally.
LY3471851 (Test) + Levocetirizine	Levocetirizine	LY3471851 administered SC in combination with levocetirizine given orally.
LY3471851 (Reference formulation)	LY3471851	LY3471851 administered SC.
Placebo	Placebo	Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Covance Dallas; 🇺🇸 Dallas, Texas, United States