Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-05 @ 11:31 AM
Study NCT ID:
NCT02015533
Status:
WITHDRAWN
Last Update Posted:
2019-03-25
First Post:
2013-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR8020 in Japanese Healthy Participants
Sponsor:
Janssen Pharmaceutical K.K.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Japanese Subjects to Assess the Safety, Pharmacokinetics and Immunogenicity of CR8020 Following Single Intravenous Administration
Status:
WITHDRAWN
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to an unexpected preliminary result obtained from the study with CR8020.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the drug) and immunogenicity (ability of a particular substance to provoke an immune response in the human body) of CR8020 in japanese healthy participants
Detailed Description:
This study is a randomized (study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo comparator is compared with the study medication to evaluate safety profile of the study medication in clinical study), single-dose study in Japanese healthy adult male participants. The study will include screening phase (28 to 2 days prior to the study medication administration), treatment phase (Study medication will be administered on Day 1), and follow-up phase (up to 99 days). Twelve participants will be randomly assigned to CR8020 50 mg/kg or placebo groups in a 2:1 ratio and receive an assigned treatment on Day 1. Safety will be assessed by evaluating adverse events, clinical laboratory tests, 12-lead Electrocardiogram, vital signs, and physical examination. Total maximum duration of participation of an individual participant will be 127 days.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CR8020FLZ1002 | OTHER | Janssen Pharmaceutical K.K., Japan | View |