Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-11 @ 10:49 AM
Study NCT ID:
NCT05473533
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2022-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Single and Multiple Doses of PRS-220 Administered by Oral Inhalation in Healthy Subjects
Sponsor:
Pieris Australia Pty Ltd
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of PRS 220 Administered by Oral Inhalation in Healthy Subjects.
Status:
COMPLETED
Status Verified Date:
2022-11
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 dose escalating study of PRS-220 administered by oral inhalation in healthy subjects
Detailed Description:
PRS-220 is a new drug being developed for treatment of idiopathic pulmonary fibrosis (IPF). The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple ascending doses of PRS-220 in healthy subjects.
Study Oversight
Has Oversight DMC:
True
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?: