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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: ATR-107 (PF-05230900) IV Infusion; Drug: Placebo SC Injection; Drug: ATR-107 (PF-05230900) SC Injection; Drug: Placebo IV Infusion

• Registration Number: NCT01162889
• Lead Sponsor: Pfizer

Brief 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.

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-15
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug dose level 8 - IV infusion	ATR-107 (PF-05230900) IV Infusion	-
Placebo - SC injection	Placebo SC Injection	-
Drug dose level 1 - SC injection	ATR-107 (PF-05230900) SC Injection	-
Drug dose level 2 - SC injection	ATR-107 (PF-05230900) SC Injection	-
Drug dose level 3- SC injection	ATR-107 (PF-05230900) SC Injection	-
Drug dose level 4 - SC injection	ATR-107 (PF-05230900) SC Injection	-
Drug dose level 5 - SC injection	ATR-107 (PF-05230900) SC Injection	-
Drug dose level 6 - IV Infusion	ATR-107 (PF-05230900) IV Infusion	-
Drug dose level 7 - IV Infusion	ATR-107 (PF-05230900) IV Infusion	-
Placebo - IV infusion	Placebo IV Infusion	-
Drug dose level 9 - IV infusion	ATR-107 (PF-05230900) IV Infusion	-

Primary Outcome Measures

Name	Time	Method
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
Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz	19 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Overland Park, Kansas, United States