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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01162889
• Other study ID #: B2281001
• Secondary ID: 3243K1-1000
• Status: Terminated
• Phase: Phase 1
• First received: June 9, 2010
• Last updated: March 13, 2012
• Start date: June 2010
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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). All participants will be healthy people.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Placebo SC Injection
Single injection
• ATR-107 (PF-05230900) SC Injection
Single intravenous infusion, 60 minute duration
• ATR-107 (PF-05230900) SC Injection
Single subcutaneous injection
• ATR-107 (PF-05230900) SC Injection
Single subcutaneous injection
• ATR-107 (PF-05230900) SC Injection
Single subcutaneous injection
• ATR-107 (PF-05230900) SC Injection
Single subcutaneous injection
• ATR-107 (PF-05230900) IV Infusion
Single subcutaneous injection
• ATR-107 (PF-05230900) IV Infusion
Single intravenous infusion, 60 minute duration
• ATR-107 (PF-05230900) IV Infusion
Single intravenous infusion, 60 minute duration
• Placebo IV Infusion
Single intravenous infusion, 60 minute duration
• ATR-107 (PF-05230900) IV Infusion
Single intravenous infusion, 60 minute duration

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz		19 months	No

External Links

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