Ignite Creation Date:
2024-05-06 @ 8:11 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02681861
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2016-01-21
Brief Title:
A Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects
Sponsor:
Astellas Pharma Europe BV
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 1 Single Ascending Dose Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2017-01
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 to evaluate the safety and tolerability of single ascending intravenous doses and single subcutaneous sc doses of ASP6294 in healthy young male and female subjects
This study will also evaluate the pharmacokinetics pk of single ascending intravenous doses and single ascending sc doses of ASP6294 determine the effect of ASP6294 administered intravenously and sc on the serum levels of circulating total Nerve Growth Factor NGF explore a potential gender difference in safety tolerability and pk of single intravenous dose and single sc doses administrations of ASP6294 as well as determine the maximum tolerated dose MTD of single intravenous doses and single sc doses of ASP6294
Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc
This study will also evaluate the pharmacokinetics pk of single ascending intravenous doses and single ascending sc doses of ASP6294 determine the effect of ASP6294 administered intravenously and sc on the serum levels of circulating total Nerve Growth Factor NGF explore a potential gender difference in safety tolerability and pk of single intravenous dose and single sc doses administrations of ASP6294 as well as determine the maximum tolerated dose MTD of single intravenous doses and single sc doses of ASP6294
Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc
Detailed Description:
The study consists of two parts Part 1 ascending intravenous dose and Part 2 ascending subcutaneous dose Subjects will participate in either Part 1 or Part 2 Subjects in Part 1 and Part 2 will have a residential period of 6 days followed by outpatient visits
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-003451-59 | EUDRACT_NUMBER | None | None |