Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-31 @ 5:28 PM
Study NCT ID:
NCT02681861
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2016-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
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 B.V.
Organization:
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:
True
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 |
|---|---|---|---|---|
| 2014-003451-59 | EUDRACT_NUMBER | None | View |