A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers
A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Nov 2012
Longer than P75 for phase_1 healthy
1 active site
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
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 5, 2012
CompletedFirst Posted
Study publicly available on registry
December 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 19, 2014
June 1, 2014
1.6 years
November 5, 2012
June 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Incidence of dose limiting or intolerable treatment related AEs
60 days
Incidence of treatment emergent AEs
60 days
Incidence of abnormal laboratory findings
60 days
Changes from baseline in safety laboratory assessments
60 days
Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters
60 days
Incidence of anti-drug-antibodies
60 days
Severity of treatment emergent AEs
60 days
Causal relationship of treatment emergent AEs
60 days
Secondary Outcomes (7)
Area under the Concentration-Time Curve (AUC)
60 days
Maximum Observed Plasma Concentration (Cmax)
60 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
60 days
PK parameter estimates including T1/2.
60 days
Systemic Clearance (CL)
60 days
- +2 more secondary outcomes
Study Arms (2)
1. Placebo
PLACEBO COMPARATORPlacebo
2.0
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.
- BMI between 18.5 to 32 kg/m2.
- Total body weight ≥40 kg and ≤120 kg.
You may not qualify if:
- Previous treatment with an antibody within 6 months prior to Day 1.
- Pregnant or nursing females; females of childbearing potential.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
November 5, 2012
First Posted
December 4, 2012
Study Start
November 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 19, 2014
Record last verified: 2014-06