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Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects

NCT02675023 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 603

Last updated 2019-10-15

No results posted yet for this study

Summary

This study will assess the pharmacokinetic (PK) and safety of a single 0.8 mL (40 mg) subcutaneous (SC) dose of M923 administered via an auto-injector (AI) or a prefilled syringe (PFS) in healthy subjects.

Conditions

  • Healthy

Interventions

BIOLOGICAL

M923

Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)

Sponsors & Collaborators

  • Momenta Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • John Caminis, MD · Shire

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675023 on ClinicalTrials.gov