A Phase I Study of LY3471851 in Healthy Participants

NCT05565729 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17603J1P-MC-KFAN
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Interleukin-2; NKTR-358; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851

  PK: Cmax of LY3471851

  Predose up to 56 days postdose

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851

  PK: AUC of LY3471851

  Predose up to 56 days postdose

Study Arms (4)

LY3471851 (Test formulation)

EXPERIMENTAL

LY3471851 administered subcutaneously (SC).

Drug: LY3471851

LY3471851 (Test) + Levocetirizine

EXPERIMENTAL

LY3471851 administered SC in combination with levocetirizine given orally.

Drug: LY3471851; Drug: Levocetirizine

LY3471851 (Reference formulation)

ACTIVE COMPARATOR

LY3471851 administered SC.

Drug: LY3471851

Placebo

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3471851 DRUG

Administered SC.

Also known as: NKTR-358

LY3471851 (Reference formulation); LY3471851 (Test formulation); LY3471851 (Test) + Levocetirizine

Placebo DRUG

Administered SC.

Placebo

Levocetirizine DRUG

Administered orally.

LY3471851 (Test) + Levocetirizine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nektar Therapeutics: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Covance Dallas

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

levocetirizine

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 4, 2022
• Study Start: October 5, 2022
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)