A Phase I Study of LY3471851 in Healthy Participants

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05565729
• Other study ID #: 17603
• Secondary ID: J1P-MC-KFAN
• Status: Completed
• Phase: Phase 1
• Start date: October 5, 2022
• Est. completion date: February 23, 2023

Study information

• Verified date: November 2, 2023
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3471851
Administered SC.
• Placebo
Administered SC.
• Levocetirizine
Administered orally.

Locations

Country	Name	City	State
United States	Covance Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Nektar Therapeutics	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

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