HealthyPhase 1NCT01162889

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

A Phase 1 study testing ATR-107 (PF-05230900) SC Injection and ATR-107 (PF-05230900) IV Infusion in people with Healthy, run by Pfizer at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ATR-107 (PF-05230900) SC Injection and ATR-107 (PF-05230900) IV Infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 2 sitesUnited States
Study dates: Jun 2010to Jan 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Females of non-childbearing potential
Body mass index between 17.5 to 30.5 and body weight > 50 kg

Who cannot join

History of significant medical illness
Positive urine drug screen or alcohol dependance
Smoking > 10 cigarettes per day

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Pfizer Investigational Site
New Haven, Connecticut, 06511
Pfizer Investigational Site
Overland Park, Kansas, 66211

Other trials in United States

About this study

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

Read the detailed description

First in human single dose study. Study terminated 12 October 2011. The ATR-107 Development team reached a recommendation to terminate further development of ATR-107 (PF-05230900). This was based on a number of factors, including development of anti-drug antibodies in approximately 70% of subjects in the First-in-Human study in healthy volunteers (B2281001). This recommendation is not based on adverse events observed in study B2281001.

Conditions: Healthy
Being tested: Placebo SC Injection, ATR-107 (PF-05230900) SC Injection, ATR-107 (PF-05230900) IV Infusion, Placebo IV Infusion
Keywords: pharmacokinetics, Crohn's disease
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo SC InjectionDrug
Single injection
ATR-107 (PF-05230900) SC InjectionDrug
Single intravenous infusion, 60 minute duration
ATR-107 (PF-05230900) SC InjectionDrug
Single subcutaneous injection
ATR-107 (PF-05230900) SC InjectionDrug
Single subcutaneous injection
ATR-107 (PF-05230900) SC InjectionDrug
Single subcutaneous injection
ATR-107 (PF-05230900) SC InjectionDrug
Single subcutaneous injection
ATR-107 (PF-05230900) IV InfusionDrug
Single subcutaneous injection
ATR-107 (PF-05230900) IV InfusionDrug
Single intravenous infusion, 60 minute duration
ATR-107 (PF-05230900) IV InfusionDrug
Single intravenous infusion, 60 minute duration
Placebo IV InfusionDrug
Single intravenous infusion, 60 minute duration
ATR-107 (PF-05230900) IV InfusionDrug
Single intravenous infusion, 60 minute duration

Study groups in NCT01162889
Study group	Role	What they receive
Placebo - SC injection	Placebo comparator	Not described Receives: Drug: Placebo SC Injection
Drug dose level 1 - SC injection	Experimental	Not described Receives: Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 2 - SC injection	Experimental	Not described Receives: Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 3- SC injection	Experimental	Not described Receives: Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 4 - SC injection	Experimental	Not described Receives: Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 5 - SC injection	Experimental	Not described Receives: Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 6 - IV Infusion	Experimental	Not described Receives: Drug: ATR-107 (PF-05230900) IV Infusion
Drug dose level 7 - IV Infusion	Experimental	Not described Receives: Drug: ATR-107 (PF-05230900) IV Infusion
Drug dose level 8 - IV infusion	Experimental	Not described Receives: Drug: ATR-107 (PF-05230900) IV Infusion
Placebo - IV infusion	Placebo comparator	Not described Receives: Drug: Placebo IV Infusion
Drug dose level 9 - IV infusion	Experimental	Not described Receives: Drug: ATR-107 (PF-05230900) IV Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 20 months
Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz
Measured: 19 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Jan 2012

First posted15 Jul 2010 (estimated)
Study startJun 2010
Primary completionJan 2012
Study completionJan 2012

Why it stopped: See termination reason in detailed description.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01162889
Sponsor's protocol ID: B2281001
Other IDs: 3243K1-1000
Status last verified: Mar 2012
First submitted: 9 Jun 2010
Last updated: 15 Mar 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ATR-107 Administered Subcutaneously And Intravenously To Healthy Subjects
ClinicalTrials.gov ID: NCT01162889
Acronym / sponsor ID: B2281001
Conditions: Healthy
Keywords: pharmacokinetics, Crohn's disease
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 70 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 15 Jul 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 11

Arm	Type	Receives
Placebo - SC injection	Placebo comparator	Drug: Placebo SC Injection
Drug dose level 1 - SC injection	Experimental	Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 2 - SC injection	Experimental	Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 3- SC injection	Experimental	Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 4 - SC injection	Experimental	Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 5 - SC injection	Experimental	Drug: ATR-107 (PF-05230900) SC Injection
Drug dose level 6 - IV Infusion	Experimental	Drug: ATR-107 (PF-05230900) IV Infusion
Drug dose level 7 - IV Infusion	Experimental	Drug: ATR-107 (PF-05230900) IV Infusion
Drug dose level 8 - IV infusion	Experimental	Drug: ATR-107 (PF-05230900) IV Infusion
Placebo - IV infusion	Placebo comparator	Drug: Placebo IV Infusion
Drug dose level 9 - IV infusion	Experimental	Drug: ATR-107 (PF-05230900) IV Infusion

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Females of non-childbearing potential
Body mass index between 17.5 to 30.5 and body weight > 50 kg

Key exclusion criteria (3 listed)

History of significant medical illness
Positive urine drug screen or alcohol dependance
Smoking > 10 cigarettes per day

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo SC InjectionSingle injection	Drug	Placebo - SC injection
ATR-107 (PF-05230900) SC InjectionSingle intravenous infusion, 60 minute duration	Drug	Drug dose level 1 - SC injection
ATR-107 (PF-05230900) SC InjectionSingle subcutaneous injection	Drug	Drug dose level 2 - SC injection
ATR-107 (PF-05230900) SC InjectionSingle subcutaneous injection	Drug	Drug dose level 3- SC injection
ATR-107 (PF-05230900) SC InjectionSingle subcutaneous injection	Drug	Drug dose level 4 - SC injection
ATR-107 (PF-05230900) SC InjectionSingle subcutaneous injection	Drug	Drug dose level 5 - SC injection
ATR-107 (PF-05230900) IV InfusionSingle subcutaneous injection	Drug	Drug dose level 6 - IV Infusion
ATR-107 (PF-05230900) IV InfusionSingle intravenous infusion, 60 minute duration	Drug	Drug dose level 7 - IV Infusion
ATR-107 (PF-05230900) IV InfusionSingle intravenous infusion, 60 minute duration	Drug	Drug dose level 8 - IV infusion
Placebo IV InfusionSingle intravenous infusion, 60 minute duration	Drug	Placebo - IV infusion
ATR-107 (PF-05230900) IV InfusionSingle intravenous infusion, 60 minute duration	Drug	Drug dose level 9 - IV infusion

Primary outcome

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.
Time frame: 20 months
Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz
Time frame: 19 months

Results and safety

The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATR-107 (PF-05230900) SC Injection and ATR-107 (PF-05230900) IV Infusion in people with Healthy, run by Pfizer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01162889.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2012.