Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05195723
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2021-11-29
Brief Title:
Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers
Sponsor:
Moleculin Biotech Inc
Organization:
Moleculin Biotech Inc
Study Overview
Official Title:
A Phase 1a First-in-Human Randomized Double-Blind Placebo-Controlled Overlapping Single and Multiple Ascending Dose Escalation Study of WP1122 to Establish Maximum Tolerated Dose and Evaluate Pharmacokinetics
Status:
COMPLETED
Status Verified Date:
2023-02
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 study in healthy human volunteers will investigate the effects of a single dose SAD and multiple days of dosing MAD of WP1122 administered as an oral PO solution Dose escalation will take place in sequential SAD cohorts and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated This study in healthy volunteers will explore safety and PK and subsequent clinical development will be in patients infected with SARS CoV-2 in the setting of continued safety and favorable riskbenefit
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