Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Study Overview
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Brief Summary
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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.

Official Title
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An Intra-subject Dose Escalation Phase 1 Study to Determine the Safety and Tolerability of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Conditions
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Myopia

Intervention / Treatment
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* Drug: SHJ - Low concentration
* Drug: SHJ - Mid concentration
* Drug: SHJ - High concentration
* Drug: SHJ - Maximum tolerated


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-cycloplegic sphere from +1.50 to -4.75 Diopters in one or both eyes. A minor able to complete all study assessments and comply with the protocol and has a parent or caregiver willing and able to follow study instructions, comply with the protocol and attend study visits with the subject as required, in the opinion of the Investigator. Literate and able to orally communicate. Exclusion Criteria: Non-cycloplegic sphere worse than -4.75 Diopters Axial length > 26 mm Hyperopia worse than +1.50 Diopters Anisometropia (difference of myopic power >2.00 D). Astigmatism > 1.5 D. Intraocular pressure > 21 mm Hg or < 6 mm Hg.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Single-center, Open-label, first-in-human dose-escalation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.025% SHJ002<br>0.025% SHJ002 Sterile Ophthalmic Solution | Drug: SHJ - Low concentration<br>* Topical ophthalmic<br>|
| Experimental: 0.080% SHJ002<br>0.080% SHJ002 Sterile Ophthalmic Solution | Drug: SHJ - Mid concentration<br>* Topical ophthalmic<br>|
| Experimental: 0.25% SHJ002<br>0.25% SHJ002 Sterile Ophthalmic Solution | Drug: SHJ - High concentration<br>* Topical ophthalmic<br>|
| Experimental: SHJ002 - Maximum tolerated concentration<br>Maximum tolerated concentration of SHJ002 | Drug: SHJ - Maximum tolerated<br>* SHJ - Maximum tolerated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia