Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Sunhawk Vision Biotech

Status and phase: Completed; Phase 1

Conditions: Myopia

Treatments: Drug: SHJ - Mid concentration; Drug: SHJ - Low concentration; Drug: SHJ - Maximum tolerated; Drug: SHJ - High concentration

Study type: Interventional

Funder types: Industry

Identifiers

NCT04928144

SHJ002-CS201

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 10 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

0.025% SHJ002

Experimental group

Description:

0.025% SHJ002 Sterile Ophthalmic Solution

Treatment:

Drug: SHJ - Low concentration

0.080% SHJ002

Experimental group

Description:

0.080% SHJ002 Sterile Ophthalmic Solution

Treatment:

Drug: SHJ - Mid concentration

0.25% SHJ002

Experimental group

Description:

0.25% SHJ002 Sterile Ophthalmic Solution

Treatment:

Drug: SHJ - High concentration

SHJ002 - Maximum tolerated concentration

Experimental group

Description:

Maximum tolerated concentration of SHJ002

Treatment:

Drug: SHJ - Maximum tolerated