Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects

NCT02923583 | Completed Phase 1

• 1 other identifier: MOM-M834-001
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ® following administration of a single-dose in healthy volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum serum concentration (Cmax)

  Pre-dose; and post dose through day 85.

• Area under the serum concentration (AUC) versus time curve from zero to last quantifiable concentration [AUC(0-last)]

  Pre-dose; and post dose through day 85.

• Area under the concentration-time curve in serum from time zero extrapolated to infinity [AUC(0-inf)]

  Pre-dose; and post dose through day 85.

Secondary Outcomes (2)

• The incidence of anti-drug antibodies (ADAs)

  Pre-dose; and post dose through day 85.

• Count and percentages of adverse events by treatment group.

  Time of dosing up-to Day 85 post-dose.

Study Arms (3)

M834

EXPERIMENTAL

M834 (abatacept biosimilar candidate)

Biological: M834

US Orencia®

ACTIVE COMPARATOR

US-sourced Orencia® (abatacept)

Biological: US-Sourced Orencia®

EU Orencia®

ACTIVE COMPARATOR

EU-sourced Orencia® (abatacept)

Biological: EU-Sourced Orencia®

Interventions

M834 BIOLOGICAL

M834

US-Sourced Orencia® BIOLOGICAL

Also known as: Abatacept

US Orencia®

EU-Sourced Orencia® BIOLOGICAL

Also known as: Abatacept

EU Orencia®

Eligibility Criteria

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

You may qualify if:

• Male or females 18 to 55 years of age, inclusive (of any ethnic origin).
• Healthy as determined by medical history, physical examination, vital signs, and 12 lead electrocardiography (ECG) at screening.
• Body mass index (BMI) between 18 and 32 kg/m2.
• Body weight between 50.0 and 100.0 kg, inclusive.
• Has smoked no more than 10 cigarettes, 3 cigars, or 3 pipes/day for at least 1 month prior to screening and is willing to comply with smoking restrictions during confinement at the study center.
• Willing and able to comply with the requirements of the study.
• Willing and able to sign a written informed consent.

You may not qualify if:

• History and/or current presence of clinically significant angioedema, clinically significant hypersensitivity, or severe allergic reactions (either spontaneous or following drug administration), also including known or suspected clinically relevant drug hypersensitivity to any components of the study drugs or comparable drugs, or latex.
• History of invasive systemic fungal infections (e.g., histoplasmosis, coccidioidomycosis) or other severe opportunistic infections; subjects with well-controlled or mild recurrent or chronic local fungal infections (e.g., tinea versicolor, onychomycosis, athlete's foot) may be included at the discretion of the Investigator.
• A serious infection (associated with hospitalization and/or required intravenous anti-infectives) within 6 months of study drug administration or a significant infection requiring oral or topical anti-infectives within 4 weeks of study drug administration.
• Any minor infection within 2 weeks of admission to the clinical unit on Day -1 that, in the opinion of the Investigator, may require systemic therapy or otherwise impact safety or participation in the study.
• Herpes zoster infection in the last year or more than 1 herpes zoster infections in his/her lifetime.
• Frequent chronic or recurrent infections (defined as \>3 a year requiring prescribed antibiotic treatment; subjects with \>3 viral upper respiratory infections may be considered based on Investigator discretion).
• Previous administration of abatacept, belatacept, or biosimilar candidates referencing abatacept or belatacept.
• Receipt of another recombinant human monoclonal antibody within 6 months prior to dosing in this trial, or within 5 half-lives, or within the expected period of pharmacodynamic effect; whichever is longest.
• Intake of any study drug in another trial within 3 months prior to dosing in this trial or have received the last dose of an investigational drug \>3 months ago but who are on extended follow-up, or planned dosing of an investigational drug (other than for this study) during the course of this trial.
• History of alcohol abuse in the past year, or history of regular consumption of alcohol, or unwillingness to comply with the alcohol restrictions outlined.
• History of drug abuse.
• Donation of blood within 3 months or blood products (e.g., platelets within 6 weeks, plasma within 7 days) prior to dosing.
• Use of any prescribed or non-prescribed medication, dietary supplements or herbal medication during the 2 weeks prior to dosing.
• History of or current congestive heart failure.
• History of or current signs or symptoms of demyelinating disease including optic neuritis and/or multiple sclerosis.

Sponsors & Collaborators

• Momenta Pharmaceuticals, Inc.: lead
• Mylan Inc.: collaborator

Study Sites (2)

Covance Clincal Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Location

Hammersmith Medicines Research (HMR)

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Candida Fratazzi, MD

  Momenta Pharmaceuticals, Inc.

  STUDY DIRECTOR

• James Bush, MBChB, PhD, MRCS(Ed), MFPM

  Covance Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: October 4, 2016
• Study Start: October 1, 2016
• Primary Completion: July 21, 2017
• Study Completion: July 21, 2017
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

GB (2)