A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518) (Willow 1)

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Biological: Pegilodecakin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03267732

J1L-AM-JZGE (Other Identifier)

AM0010-801 (Other Identifier)

17297

Details and patient eligibility

About

To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.

Full description

This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female between 18 and 55 years of age, inclusive
2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
3. Must be HIV negative by HIV 1/0/2 testing
4. Must be Hepatitis B (HBV) surface antigen negative
5. Must be Hepatitis C (HCV) antibody negative
6. Females must have a negative serum pregnancy test
7. Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug

Exclusion criteria

1. Pregnant or lactating subjects
2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
3. Have poor venous access and are unable to donate blood
4. Have been vaccinated within 90 days of study dosing
5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
6. Have history of significant drug sensitivity or drug allergy.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

1

Active Comparator group

Description:

Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ

Treatment:

Biological: Pegilodecakin

2

Active Comparator group

Description:

Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ

Treatment:

Biological: Pegilodecakin