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A Trial of PF-06252616 in Ambulatory Participants With LGMD2I

NCT02841267 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-10-19

Study results available
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Summary

The investigational product PF 06252616, a humanized anti myostatin monoclonal antibody that neutralizes myostatin (GDF8) is in development for the treatment of Limb Girdle Muscular Dystrophy 2I (LGMD2I) to preserve and/or improve muscle function.

This study will provide the clinical assessment of the safety, tolerability, Pharmacokinetics and Pharmacodynamics of PF 06252616 following repeat IV doses in ambulatory adults with LGMD2I.

Conditions

  • LGMD2I

Interventions

DRUG

PF 06252616

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Kathryn Wagner

    lead OTHER

Principal Investigators

  • Kathryn R Wagner, MD/PhD · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02841267 on ClinicalTrials.gov