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

Healthy Adult Subjects Clinical Trial

— Willow 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381547
• Other study ID #: 17298
• Secondary ID: J1L-AM-JZGFAM001
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2017
• Est. completion date: February 11, 2018

Study information

• Verified date: April 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 11, 2018
• Est. primary completion date: February 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Biological:
• Pegilodecakin
Pegilodecakin Alone

Locations

Country	Name	City	State
United States	PPD Development	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	ARMO BioSciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters, Cmax	maximal plasma concentration (Cmax)	43 days
Primary	Pharmacokinetic parameters, Tmax	maximal concentration (Tmax)	43 days
Primary	Pharmacokinetic parameters, AUC	area under the plasma concentration curve (AUC)	43 days
Primary	Pharmacokinetic parameters, CL/F	clearance (CL/F).	43 days
Secondary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, and vital signs.	43 days