NCT02531815|CompletedPhase 1

Dose Escalation Study of PF-06741086 In Healthy Subjects

A Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Intravenous Or Subcutaneous Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06741086 In Healthy Subjects And An Open-label Evaluation In Healthy Japanese Subjects

Pfizer ClinicalTrials.gov

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2 other identifiers

B78410012015-001821-17

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2015

StartedAug 2015

CompletionJul 2016

Brief Summary

This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline

Completed

Started Aug 2015

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

11 months study duration

Study Start

First participant enrolled

August 1, 2015

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed

22 days until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed

Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

August 3, 2015

Last Update Submit

August 10, 2016

Conditions

Healthy

Keywords

safetytolerabilitypharmacokineticspharmacodynamicsPhase 1first in humanmonoclonal antibodytissue factor pathway inhibitorjapanese

Outcome Measures

Primary Outcomes (7)

Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
Day 1 up to Day 84
Percentage of subjects with laboratory abnormalities
Day 1 up to Day 84
Number of subjects with change from baseline in vital signs
blood pressure, pulse rate, temperature, respiration rate
Day 1 up to Day 84
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Day 1 to Day 84
Percentage of subjects with changes from baseline in physical examination
Day 1 to Day 84
Percentage of subjects with infusion site reactions
Day 1 up to Day 7
Percentage of subjects with injection site reactions
Day 1 to Day 7

Secondary Outcomes (18)

Plasma PF-06741086 concentrations
Day 1 up to Day 84
Maximum observed plasma concentration (Cmax)
Day 1 up to Day 84
Time for Cmax (Tmax)
Day 1 up to Day 84
Area under the curve from time zero to last quantifiable concentration (AUClast)
Day 1 up to Day 84
Terminal half-life (t 1/2)
Day 1 up to Day 84
+13 more secondary outcomes