CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
PF 06252616drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02841267
NCT02841267Phase 2Completed

A Phase 1b/2, Open-Label, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of PF-06252616 in Ambulatory Participants With LGMD2I

Kathryn Wagner·interventional·Posted Jul 22, 2016·Updated Oct 19, 2020

In Brief

A Phase 2 clinical trial evaluating PF 06252616 for LGMD2I. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLGMD2I
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 22, 2016
Enrollment StartJul 1, 2016
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.9 years ago

Interventions

PF 06252616drug