A Single-Dose Study of LY3471851 in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04998487
• Other study ID #: 17604
• Secondary ID: J1P-MC-KFAL
• Status: Completed
• Phase: Phase 1
• Start date: August 16, 2021
• Est. completion date: July 6, 2022

Study information

• Verified date: November 15, 2023
• Source: Nektar Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it when administered under the skin in healthy participants. The study will also evaluate the safety and tolerability of LY3471851. The study is expected to last up to 87 days for each participant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 6, 2022
• Est. primary completion date: July 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Overtly healthy males or females, as determined by medical history and physical examination.

• Body weight greater than 55 kilograms (kg) and body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²)

Exclusion Criteria:

• Have evidence of clinically significant active infection, including fever 100.5ºF (38ºC) or above, within 28 days of dosing or Day 1 (before dosing)

• Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. Examples include but are not limited to infections requiring intravenous antibiotics, hospitalization, or prolonged treatment

• Are immunocompromised per investigator judgment.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3471851
Administered SC.

Locations

Country	Name	City	State
United States	LabCorp CRU, Inc.	Daytona Beach	Florida

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