Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862623
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-04-28
Brief Title:
Single and Multiple Ascending Dose Study of AER-01
Sponsor:
Aer Therapeutics
Organization:
Aer Therapeutics
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 1 Study of AER-01 Solution for Inhalation Delivered Via Nebulizer As a First-In-Human Single Ascending Dose in Healthy Volunteers Part A and a 7-day Multiple Ascending Dose in Healthy VolunteersPart B
Status:
RECRUITING
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 is a first-in-human randomized double-blind placebo-controlled Phase 1 study of AER-01 solution for inhalation delivered via nebulizer to assess the safety tolerability and PK of AER-01 The study will be conducted in 2 parts a single ascending dose SAD part in HVs Part A and a 7-day multiple ascending dose MAD part in HVsPart B
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