Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Phase 1

Completed

• Conditions: Myopia
• Interventions: Drug: SHJ - Low concentration; Drug: SHJ - Mid concentration; Drug: SHJ - High concentration; Drug: SHJ - Maximum tolerated

• Registration Number: NCT04928144
• Lead Sponsor: Sunhawk Vision Biotech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Study Start: 2021-07-02
• Primary Completion: 2021-09-17
• Study Completion: 2021-09-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
0.025% SHJ002	SHJ - Low concentration	0.025% SHJ002 Sterile Ophthalmic Solution
0.080% SHJ002	SHJ - Mid concentration	0.080% SHJ002 Sterile Ophthalmic Solution
0.25% SHJ002	SHJ - High concentration	0.25% SHJ002 Sterile Ophthalmic Solution
SHJ002 - Maximum tolerated concentration	SHJ - Maximum tolerated	Maximum tolerated concentration of SHJ002

Primary Outcome Measures

Name	Time	Method
Change from baseline in best corrected visual acuity	3 days (Part 1) and 28 days (Part 2)	Change from baseline in best corrected visual acuity
Incidence of Adverse Events	3 days (Part 1) and 28 days (Part 2)	Incidence of Adverse Events

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung City, Taiwan