Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05969236
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2023-07-24
Brief Title:
A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults
Sponsor:
Shanghai Medinno Pharmaceutical Technology Co Ltd
Organization:
Shanghai Medinno Pharmaceutical Technology Co Ltd
Study Overview
Official Title:
A Phase 1 First-in-Human Single-center Randomized Double-masked Placebo-controlled Study to Evaluate the Safety Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of MDI-1228_mesylate Ophthalmic Solution by Local Instillation in Adult Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-07
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:
The main goal of this clinical trial is to evaluate the safety tolerability and pharmacokinetics PK profiles of MDI-1228_mesylate Ophthalmic Solution in healthy adult participants
Participants will receive either of the following treatment
MDI-1228_mesylate Ophthalmic Solution or
Placebo
Researchers will observe any changes in health if any in participants receiving the study treatment to evaluate the safety and tolerability of the study drug Researchers will also collect several blood samples from participants to study PK profiles of the drug
Note
PK profiles how the drug interacts with the body placebo a harmless substance that contains no active agents tolerability how well you can tolerate the drug
Participants will receive either of the following treatment
MDI-1228_mesylate Ophthalmic Solution or
Placebo
Researchers will observe any changes in health if any in participants receiving the study treatment to evaluate the safety and tolerability of the study drug Researchers will also collect several blood samples from participants to study PK profiles of the drug
Note
PK profiles how the drug interacts with the body placebo a harmless substance that contains no active agents tolerability how well you can tolerate the drug
Detailed Description:
None
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?:
None