Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097747
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2004-11-30
Brief Title:
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
Sponsor:
Affymax
Organization:
Affymax
Study Overview
Official Title:
A Phase 1 Double-blind Placebo-controlled Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2012-12
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 pharmacokinetics PK and minimum pharmacologically active dose of peginesatide in Healthy Volunteers
Detailed Description:
This was a Phase 1 double-blind placebo-controlled trial of peginesatide an erythropoiesis stimulating agent with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort In each cohort of 7 participants a ratio of 52 participants was randomly assigned to receive a single dose of peginesatide or placebo respectively administered as an intravenous infusion Planned peginesatide dose levels were to escalate by cohort The study was conducted at a single clinical center
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 |
|---|---|---|---|
| 2004-001655-11 | EUDRACT_NUMBER | None | None |