Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Drug: SHJ - Low concentration; Drug: SHJ - Mid concentration; Drug: SHJ - High concentration; Drug: SHJ - Maximum tolerated

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan
    • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Sunhawk Vision Biotech, Inc.
• Investigators: Study Director: Suh-Hang H. Juo, MD, Ph.D., Sunhawk Vision Biotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): September 17, 2021
• Study Completion (Actual): September 17, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SHJ002-CS201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No