A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518) (Willow 2)

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Biological: Pegilodecakin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03381547

17298

AM0010-802 (Other Identifier)

J1L-AM-JZGF (Other Identifier)

Details and patient eligibility

About

To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.

Full description

An open label, randomized, single dose, 3-way crossover study to evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.

Enrollment: 12 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. Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from Screening throughout the duration of study dosing and for 30 days following the last dose of study drug.
8. 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: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

A

Active Comparator group

Description:

Pegilodecakin: Dose level depending on weight will be 0.8 mg or 1.6 mg, dose formulation 4 mg/mL.

Treatment:

Biological: Pegilodecakin

B

Active Comparator group

Description:

Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 4 mg/mL.

Treatment:

Biological: Pegilodecakin

C

Active Comparator group

Description:

Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 2 mg/mL.

Treatment:

Biological: Pegilodecakin