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

NCT03381547 | Completed Phase 1 FDA Drug

• 3 other identifiers: 17298J1L-AM-JZGFAM0010-802
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic parameters, Cmax

  maximal plasma concentration (Cmax)

  43 days

• Pharmacokinetic parameters, Tmax

  maximal concentration (Tmax)

  43 days

• Pharmacokinetic parameters, AUC

  area under the plasma concentration curve (AUC)

  43 days

• Pharmacokinetic parameters, CL/F

  clearance (CL/F).

  43 days

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  43 days

Study Arms (3)

A

ACTIVE COMPARATOR

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

Biological: Pegilodecakin

B

ACTIVE COMPARATOR

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

Biological: Pegilodecakin

C

ACTIVE COMPARATOR

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

Biological: Pegilodecakin

Interventions

Pegilodecakin BIOLOGICAL

Pegilodecakin Alone

Also known as: LY3500518, AM0010

A; B; C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 and 55 years of age, inclusive
• Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
• Must be HIV negative by HIV 1/0/2 testing
• Must be Hepatitis B (HBV) surface antigen negative
• Must be Hepatitis C (HCV) antibody negative
• Females must have a negative serum pregnancy test
• 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.
• 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

You may not qualify if:

• Pregnant or lactating subjects
• Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
• Have poor venous access and are unable to donate blood
• Have been vaccinated within 90 days of study dosing
• Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
• Have history of significant drug sensitivity or drug allergy.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• ARMO BioSciences: collaborator

Study Sites (1)

PPD Development

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

pegilodecakin; AM0010

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 22, 2017
• Study Start: December 18, 2017
• Primary Completion: February 11, 2018
• Study Completion: February 11, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)