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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01162889
First received: June 9, 2010
Last updated: March 13, 2012
Last verified: March 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014