Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962645
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-06-07
Brief Title:
Phase 1 Study Into Pharmacokinetics and Food Effect of Vapendavir in Healthy Participants and Participants With COPD
Sponsor:
Altesa Biosciences Inc
Organization:
Altesa Biosciences Inc
Study Overview
Official Title:
A Phase 1 Study to Confirm the Single- and Multiple-dose Pharmacokinetics and to Evaluate Food Effect of Vapendavir in Healthy Participants and Participants With COPD
Status:
COMPLETED
Status Verified Date:
2024-07
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:
Vapendavir VPV is potent virostatic antiviral agent active against all known enterovirus species VPV binds to the viral capsid thereby inhibiting viral attachment to the target cell and independently preventing release of viral RNA ribonucleic acid into the cell Alt VPV-101 is meant to investigate vapendavir in patients with chronic obstructive pulmonary disease COPD who develop a rhinoviral infection This is a Phase 1 open-label unblinded study The primary objective of this study is to characterize single and multiple dose plus a loading dose plasma PK profiles of VPV in healthy participants Group A and participants with COPD Group B Group A is an open-label 2-sequence and up to a 3-period cross-over study to assess the single-dose PK parameters and safety of VPV Healthy participants may opt to participate in only the first 2 periods all 3 periods or BID dosing but it is preferred that participants complete all 3 periods Group B is an open-label multi-dose investigation of VPV PK parameters and safety in participants with COPD Post-dose follow up will continue for a minimum of 14 days and a maximum of 30 days depending on which Group the participant is in and which periods said participant completes There is a target for up to 24 adult participants comprised of healthy participants and participants with COPD
Detailed Description:
Vapendavir VPV has been in development for the treatment of infections with human rhinovirus RV and other respiratory enteroviruses for over a decade with over 640 healthy adults and participants with Asthma receiving treatment across 7 clinical studies Vapendavir is a potent and broad spectrum virostatic agent active against 97 of RV A and B serotypes no available assay for RV C but clinical data indicate sensitivity similar to A and B and 89 of other enteroviruses evaluated Vapendavir has exhibited an acceptable safety and tolerability profile to date with no appreciable safety concerns with single doses up to 1056 milligram mg and daily doses up to 528 mg 264 mg twice daily for up to 6 or 10 days
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