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

NCT02923583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2017-10-24

No results posted yet for this study

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

Interventions

BIOLOGICAL

M834

BIOLOGICAL

US-Sourced Orencia®

BIOLOGICAL

EU-Sourced Orencia®

Sponsors & Collaborators

  • Mylan Inc.

    collaborator INDUSTRY

  • Momenta Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Candida Fratazzi, MD · Momenta Pharmaceuticals, Inc.

  • James Bush, MBChB, PhD, MRCS(Ed), MFPM · Covance Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-07-21
Completion
2017-07-21

Countries

  • 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 NCT02923583 on ClinicalTrials.gov