Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-25 @ 2:50 PM
Study NCT ID:
NCT05277350
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2022-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
Sponsor:
SNIPR Biome Aps.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, First-In-Human, Dose Escalation Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-05
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 Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose escalation study in healthy participants, investigating the safety, tolerability, recovery, and PD of multiple oral administrations of SNIPR001.
Detailed Description:
Approximately 36 healthy male and female participants will be randomized to one of 3 active oral doses of SNIPR001 or matching placebo, administered twice a day (BID) for 7 days. Subjects will be followed up until 6 months after receiving the last dose of SNIPR001.
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?: