NCT01616277

Brief Summary

The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2.2 years

First QC Date

May 25, 2012

Last Update Submit

September 23, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

  • Incidence of treatment related Adverse Events.

    Day 197

  • Severity of treatment related Adverse Events.

    Day 197

  • Incidence of abnormal lab findings.

    Day 197

  • Magnitude of abnormal lab findings.

    Day 197

  • Abnormal and clinically relevant changes in Blood Pressure.

    Day 197

  • Abnormal and clinically relevant changes in Pulse Rate.

    Day 197

  • Abnormal and clinically relevant changes in Respiratory Rate.

    Day 197

  • Abnormal and clinically relevant changes in temperature.

    Day 197

  • Abnormal and clinically relevant changes in ECG parameters.

    Day 197

Secondary Outcomes (16)

  • PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)

    Through Day 197 post dosing

  • Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay

    Through Day 197 post dosing

  • Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay

    Through Day 197 post dosing

  • Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA

    Through Day 113 post dosing

  • PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)

    Through Day 197 post dosing

  • +11 more secondary outcomes

Study Arms (7)

1

PLACEBO COMPARATOR
Biological: PF-06252616Drug: Placebo

2

PLACEBO COMPARATOR
Biological: PF-06252616Drug: Placebo

3

PLACEBO COMPARATOR
Biological: PF-06252161Drug: Placebo

4

PLACEBO COMPARATOR
Biological: PF-06252616Drug: Placebo

5

PLACEBO COMPARATOR

Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram

Biological: PF-06252616Drug: Placebo

6

PLACEBO COMPARATOR
Biological: PF-06252616Drug: Placebo

7

PLACEBO COMPARATOR
Biological: PF-06252616Drug: Placebo

Interventions

PF-06252616BIOLOGICAL

1.0 milligram per kilogram of PF-06252616, IV infusion, single dose

1
PlaceboDRUG

Placebo for PF-06252616, IV infusion, single dose

1
PF-06252161BIOLOGICAL

10.0 milligram per kilogram of PF-06252616, IV infusion, single dose

3

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
  • Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.

You may not qualify if:

  • Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
  • Weight loss or gain of \>5% within 30 days of Screening, as reported by subject.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Wojciechowski J, Purohit VS, Harnisch LO, Dua P, Tan B, Nicholas T. Population PK and PD Analysis of Domagrozumab in Pediatric Patients with Duchenne Muscular Dystrophy. Clin Pharmacol Ther. 2022 Dec;112(6):1291-1302. doi: 10.1002/cpt.2747. Epub 2022 Oct 4.

    PMID: 36104012DERIVED

Related Links

MeSH Terms

Interventions

domagrozumab

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2012

First Posted

June 11, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

US(1)