A Bioequivalence Study of Pegylated Interferon Alfa-2a (PEG-IFN Alfa-2a) Benzyl Alcohol (BA)-Free Formulation Versus PEG-IFN Alfa-2a (Pegasys) Following Subcutaneous Administration

Healthy Volunteers Clinical Trial

Official title:

An Open-Label, Randomized, Multi-Center, Single Dose, Two-Period, Two Sequence Crossover Study to Investigate the Bioequivalence of Peginterferon (PEG-IFN) Alfa-2a Benzyl Alcohol-Free Formulation Versus the Reference Market Formulation Following Subcutaneous Administration Via Prefilled Syringe in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573025
• Other study ID #: YV29573
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2015
• Last updated: March 10, 2017
• Start date: September 17, 2015
• Est. completion date: April 11, 2016

Study information

• Verified date: March 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, randomized, multi-center, single dose, two-period, two-sequence crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation versus the reference market formulation (PEG-IFN alfa-2a [Pegasys®]) following subcutaneous administration via prefilled syringe in healthy Chinese participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: April 11, 2016
• Est. primary completion date: April 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy female and male Chinese participants

• Body mass index between 19 and 28 kilograms per square meter (kg/m^2), inclusive

• Participants determined as healthy by their medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory measurements performed at the Screening visit

• Female participants of childbearing potential: willing to use highly effective methods of contraception throughout the study and for 90 days after the last dosing

• Male participants: agreement to remain abstinent or use spermicide and barrier method contraception throughout the study and for 90 days after the last dosing

• Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

• Any clinically relevant condition or history of cardiovascular, psychiatric, gastrointestinal, respiratory, renal, hepatic, hematological, lymphatic, neurological (including seizure history), musculoskeletal, genitourinary, immunological, metabolic, malignant, or dermatological disorder

• Participants who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV) or human immunodeficiency virus I and II antibody (anti-HIV I, anti-HIV II) tests at Screening

• Participants with alanine aminotransferase (ALT) above the upper limit of normal at Screening or on Day -1 of Period 1

• Any other condition or disease (other than those already stated) which, in the judgment of the Investigator, would place the participant at undue risk, interfere with the absorption, distribution, metabolism, and excretion of PEG-IFN alfa-2a, or interfere with the ability of the participant to complete the study

• History of drug or alcohol abuse within the last year before screening

• Treatment with interferon or PEG-IFN alfa-2a within 3 months prior to the first dosing

• Female participants who are pregnant, currently lactating, or have a positive serum pregnancy test at screening or have a positive urine pregnancy test on Day -1 of Period 1

• Use of any prescribed or over the counter medication or herbal medicine taken within 14 days prior to the first dosing or within 5 times the elimination half-life of the medication prior to the first dosing (whichever is longer). Exceptions are paracetamol, the contraceptive pill, hormone replacement therapy and commonly used vitamin supplements, which are permitted

• Regular smoking with consumption of more than 10 cigarettes per day or an equivalent amount of tobacco

• Participation in an investigational drug or device study within 3 months prior to the first dosing

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PEG-IFN alfa-2a BA-free formulation (Test)
Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).
• PEG-IFN alfa-2a market formulation (Reference)
Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).

Locations

Country	Name	City	State
Australia	CMAX A division of IDT Australia Limited	Adelaide	South Australia
Hong Kong	The University of Hong Kong; Pharmacy Clinical Trials	Hong Kong
Hong Kong	The Chinese University of Hong Kong; Emergency Medicine	Shatin
New Zealand	Christchurch Clinical Studies Trust	Christchurch
New Zealand	Auckland Clinical Studies Limited	Grafton
Singapore	Changi General Hospital- Parent; Department of Rheumatology	Singapore
Singapore	SingHealth Investigational Medicine Unit; Haematology	Singapore
Taiwan	China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H	Taichung
Taiwan	Taipei Medical University Hospital; Clinical Research Center	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Hong Kong,  New Zealand,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration (Cmax) for PEG-IFN alfa-2a		Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Primary	Area Under the Concentration-Time Curve (AUC) for PEG-IFN alfa-2a From Time Zero to 816 hours (AUC0-816h)		Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Secondary	Area Under the Concentration-Time Curve for PEG-IFN alfa-2a From Time Zero Extrapolated to Infinity (AUC0-inf)		Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Secondary	Time to Reach Cmax (tmax) for PEG-IFN alfa-2a		Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Secondary	Terminal Half-Life (t1/2) for PEG-IFN alfa-2a		Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Secondary	Percentage of Participants With Adverse Events		Baseline up to 35 days post last dose of PEG-IFN alfa-2a (maximum up to 17.5 weeks)