Ignite Creation Date:
2024-05-06 @ 9:39 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03047317
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2017-02-03
Brief Title:
A Pharmacokinetic Study of MABp1 in Healthy Volunteers
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase I Pharmacokinetic Study of MABp1 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-02
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:
This is an open label study of MABp1 in six healthy volunteers Participants will receive a single infusion of MABp1 at the 75 mgkg IV dose Participants will undergo blood sampling for pK analysis at 15 times points during the course of 2 weeks pre-infusion 05 hr 1 hr 15 hr 2 hr 3 hr 4 hr 5 hr 6 hr 12 hr 24 hr 48 hr 96 hr 192 hr and 336 hr In addition to pharmacokinetic data participants will be monitored for the development of treatment emergent adverse events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None