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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/6/2019
Start Date:September 5, 2017
End Date:October 30, 2017

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A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects

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

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.

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.
We found this trial at
1
site
Austin, Texas 78744
?
mi
from
Austin, TX
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