Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-12 @ 2:55 PM
Study NCT ID:
NCT02537002
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2015-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Study of PF-05230907 in Healthy Japanese Subjects
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of An Intravenous Bolus Infusion Pf-05230907 In Healthy Japanese Subjects
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is the following:
* To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
* To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
* To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
* To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects
* To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
* To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
* To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
* To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: