Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05268198
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2022-02-17
Brief Title:
SAD Study of APR002 Investigating the SafetyTolerability PharmacokineticsPharmacodynamics in Healthy Subjects
Sponsor:
Global Health Drug Discovery Institute
Organization:
Global Health Drug Discovery Institute
Study Overview
Official Title:
A Phase 1 Randomized Blinded Placebo-Controlled First-in-Human Single Ascending Dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of APR002 Administered by Inhalation in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2023-08
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 will investigate the safety tolerability pharmacokinetics and pharmacodynamics of single ascending doses of APR002 in healthy subjects
Detailed Description:
A Phase 1 Randomized Blinded Placebo-Controlled First-in-Human Single Ascending Dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of APR002 Administered by Inhalation in Healthy Volunteers
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