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An Ascending Dose Study to Evaluate M281 Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)

NCT02828046 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-10-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety, tolerability, and PK/PD of M281 after single and multiple doses in healthy volunteers.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

M281

OTHER

Placebo

Sponsors & Collaborators

  • Momenta Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • John Hogan, MPM · Momenta Director of Clinical Operations

  • Tjerk Bosji, MD · PRA Research Physician

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-05-09
Primary Completion
2017-08-08
Completion
2017-08-08

Countries

  • Netherlands

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 NCT02828046 on ClinicalTrials.gov