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This is a single-center, open-label, first-in-human dose-escalation study of SHJ002 Ophthalmic Solution in children. (Part 1) Three (3) subjects will receive each concentration of SHJ002 for 3 days in an escalation design in one eye. (Part 2) A Group of 9 additional children will receive the highest tolerated concentration for 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.025% SHJ002 | Experimental | 0.025% SHJ002 Sterile Ophthalmic Solution |
|
| 0.080% SHJ002 | Experimental | 0.080% SHJ002 Sterile Ophthalmic Solution |
|
| 0.25% SHJ002 | Experimental | 0.25% SHJ002 Sterile Ophthalmic Solution |
|
| SHJ002 - Maximum tolerated concentration | Experimental | Maximum tolerated concentration of SHJ002 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHJ - Low concentration | Drug | Topical ophthalmic |
| |
| SHJ - Mid concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in best corrected visual acuity | Change from baseline in best corrected visual acuity | 3 days (Part 1) and 28 days (Part 2) |
| Incidence of Adverse Events | Incidence of Adverse Events | 3 days (Part 1) and 28 days (Part 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suh-Hang H. Juo, MD, Ph.D. | Sunhawk Vision Biotech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39244490 | Derived | Chen JL, Lai WY, Lin RT, Juo SH, Liang CL. Safety and Tolerability of Anti-microRNA-328 Ophthalmic Solution, SHJ002, in Pediatric Subjects: First-in-Human Clinical Study. Clin Ther. 2024 Oct;46(10):768-772. doi: 10.1016/j.clinthera.2024.08.015. Epub 2024 Sep 7. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Single-center, Open-label, first-in-human dose-escalation.
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| Drug |
Topical ophthalmic |
|
| SHJ - High concentration | Drug | Topical ophthalmic |
|
| SHJ - Maximum tolerated | Drug | SHJ - Maximum tolerated |
|