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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2018-02-11

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Adult Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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A

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

Group Type ACTIVE_COMPARATOR

Pegilodecakin

Intervention Type BIOLOGICAL

Pegilodecakin Alone

B

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

Group Type ACTIVE_COMPARATOR

Pegilodecakin

Intervention Type BIOLOGICAL

Pegilodecakin Alone

C

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

Group Type ACTIVE_COMPARATOR

Pegilodecakin

Intervention Type BIOLOGICAL

Pegilodecakin Alone

Interventions

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Pegilodecakin

Pegilodecakin Alone

Intervention Type BIOLOGICAL

Other Intervention Names

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LY3500518 AM0010

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes