A 3-Way Crossover 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: | December 18, 2017 |
End Date: | February 11, 2018 |
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
To evaluate the pharmacokinetics of different dose levels and dose formulations of
pegilodecakin in healthy adult participants.
pegilodecakin in healthy adult participants.
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.
pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy
adult participants.
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.
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