A Phase I Study of LY3471851 in Healthy Participants

Nektar Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Levocetirizine; Drug: Placebo; Drug: LY3471851

Study type: Interventional

Funder types: Industry

Identifiers

NCT05565729

17603

J1P-MC-KFAN (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 4 patient groups, including a placebo group

LY3471851 (Test formulation)

Experimental group

Description:

LY3471851 administered subcutaneously (SC).

Treatment:

Drug: LY3471851

LY3471851 (Test) + Levocetirizine

Experimental group

Description:

LY3471851 administered SC in combination with levocetirizine given orally.

Treatment:

Drug: LY3471851

Drug: Levocetirizine

LY3471851 (Reference formulation)

Active Comparator group

Description:

LY3471851 administered SC.

Treatment:

Drug: LY3471851

Placebo

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo