Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01162889
First received: June 9, 2010
Last updated: March 13, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Placebo SC Injection Drug: ATR-107 (PF-05230900) SC Injection Drug: ATR-107 (PF-05230900) IV Infusion Drug: Placebo IV Infusion |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ATR-107 Administered Subcutaneously And Intravenously To Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz [ Time Frame: 19 months ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | June 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo - SC injection |
Drug: Placebo SC Injection
Single injection
|
| Experimental: Drug dose level 1 - SC injection |
Drug: ATR-107 (PF-05230900) SC Injection
Single intravenous infusion, 60 minute duration
|
| Experimental: Drug dose level 2 - SC injection |
Drug: ATR-107 (PF-05230900) SC Injection
Single subcutaneous injection
|
| Experimental: Drug dose level 3- SC injection |
Drug: ATR-107 (PF-05230900) SC Injection
Single subcutaneous injection
|
| Experimental: Drug dose level 4 - SC injection |
Drug: ATR-107 (PF-05230900) SC Injection
Single subcutaneous injection
|
| Experimental: Drug dose level 5 - SC injection |
Drug: ATR-107 (PF-05230900) SC Injection
Single subcutaneous injection
|
| Experimental: Drug dose level 6 - IV Infusion |
Drug: ATR-107 (PF-05230900) IV Infusion
Single subcutaneous injection
|
| Experimental: Drug dose level 7 - IV Infusion |
Drug: ATR-107 (PF-05230900) IV Infusion
Single intravenous infusion, 60 minute duration
|
| Experimental: Drug dose level 8 - IV infusion |
Drug: ATR-107 (PF-05230900) IV Infusion
Single intravenous infusion, 60 minute duration
|
| Placebo Comparator: Placebo - IV infusion |
Drug: Placebo IV Infusion
Single intravenous infusion, 60 minute duration
|
| Experimental: Drug dose level 9 - IV infusion |
Drug: ATR-107 (PF-05230900) IV Infusion
Single intravenous infusion, 60 minute duration
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Females of non-childbearing potential
- Body mass index between 17.5 to 30.5 and body weight > 50 kg
Exclusion Criteria:
- History of significant medical illness
- Positive urine drug screen or alcohol dependance
- Smoking > 10 cigarettes per day
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162889
Locations
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66211 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01162889 History of Changes |
| Other Study ID Numbers: | B2281001, 3243K1-1000 |
| Study First Received: | June 9, 2010 |
| Last Updated: | March 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
pharmacokinetics Crohn's disease |
ClinicalTrials.gov processed this record on May 22, 2013