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

An Open Label, Randomized, Single Dose, 3-Way Crossover Study to Evaluate the Pharmacokinetics of Different Dose Levels and Dose Formulations of AM0010 in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03381547

Acronym

Willow 2

Enrollment

Registered

2017-12-22

Start date

2017-12-18

Completion date

2018-02-11

Last updated

2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Subjects

Brief summary

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

Detailed 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.

Interventions

BIOLOGICALPegilodecakin

Pegilodecakin Alone

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic parameters, Cmax	43 days	maximal plasma concentration (Cmax)
Pharmacokinetic parameters, Tmax	43 days	maximal concentration (Tmax)
Pharmacokinetic parameters, AUC	43 days	area under the plasma concentration curve (AUC)
Pharmacokinetic parameters, CL/F	43 days	clearance (CL/F).

Secondary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	43 days	Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, and vital signs.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026