Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597422
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Single and Multiple Ascending-Dose Study to Evaluate the Safety Tolerability and Pharmacokinetics of STSP-0902 Ophthalmic Solution in Healthy Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is a Phase I clinical study to evaluate the safety tolerability and pharmacokinetic PK characteristics of STSP-0902 ophthalmic solution in healthy subjects following single and multiple administrations The study plans to enroll 80 healthy subjects and is divided into three stages the single-dose study stage the multiple-dose study stage and the tear PK study stage The single-dose and multiple-dose study stages are randomized double-blind placebo-controlled dose-escalation designs while the tear PK study stage is a single-dose open-label design
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None