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

Phase 1

Completed

• Conditions: Healthy Adult Subjects
• Interventions: Biological: Pegilodecakin

• Registration Number: NCT03381547
• Lead Sponsor: Eli Lilly and Company

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.

Study Timeline

• Study Start: 2017-12-18
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Primary Completion: 2018-02-11
• Study Completion: 2018-02-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C	Pegilodecakin	Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 2 mg/mL.
A	Pegilodecakin	Pegilodecakin: Dose level depending on weight will be 0.8 mg or 1.6 mg, dose formulation 4 mg/mL.
B	Pegilodecakin	Pegilodecakin: Dose level depending on weight will be 0.4 mg or 0.8 mg, dose formulation 4 mg/mL.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters, CL/F	43 days	clearance (CL/F).
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)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

PPD Development; 🇺🇸 Austin, Texas, United States