NCT01162889|TerminatedPhase 1

Study Stopped

See termination reason in detailed description.

Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People

Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ATR-107 Administered Subcutaneously And Intravenously To Healthy Subjects

Pfizer ClinicalTrials.gov

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2 other identifiers

B22810013243K1-1000

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJul 2010

StartedJun 2010

CompletionJan 2012

Brief Summary

This is a "first in human" study to determine the safety and tolerability of the drug after single doses. Nine doses of increasing strength will be injected or infused (given into a vein) to 9 different groups of people. One third of the participants will be given an injection or infusion of placebo (sugar water). All participants will be healthy people.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at P75+ for phase_1 healthy

Timeline

Completed

Started Jun 2010

Longer than P75 for phase_1 healthy

Geographic Reach

1 country

2 active sites

Status

terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

June 1, 2010

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed

1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed

Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

1.6 years

First QC Date

June 9, 2010

Last Update Submit

March 13, 2012

Conditions

Healthy

Keywords

pharmacokineticsCrohn's disease

Outcome Measures

Primary Outcomes (2)

Treatment-emergent AEs and SAEs, AEs leading to withdrawal, immunogenicity, injection and infusion reactions, and clinically significant changes in laboratory tests, vital signs and ECGs if reported.
20 months
Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz
19 months

Study Arms (11)

Placebo - SC injection

PLACEBO COMPARATOR

Drug: Placebo SC Injection