Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04919863
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2021-05-20
Brief Title:
Safety Tolerability and Pharmacokinetics of NTP42KVA4
Sponsor:
ATXA Therapeutics Limited
Organization:
ATXA Therapeutics Limited
Study Overview
Official Title:
A Phase I Trial to Evaluate the Safety Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42KVA4 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-02
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:
A Phase I clinical trial to assess the safety tolerability and pharmacokinetics of NTP42KVA4 following oral administration in a randomized double-blind placebo-controlled trial The trial will involve of 2 phases a single ascending dose SAD phase and a multiple ascending dose MAD phase The SAD phase will incorporate a food effect arm
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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