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.
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
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
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
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
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.
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.
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.
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?
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.