Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Sponsor

Sunhawk Vision Biotech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04928144

Collaborator

(none)

Enrollment

Location

Arms

2.5

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Drug: SHJ - Low concentration Drug: SHJ - Mid concentration Drug: SHJ - High concentration Drug: SHJ - Maximum tolerated	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Single-center, Open-label, first-in-human dose-escalation.Single-center, Open-label, first-in-human dose-escalation.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 2, 2021

Actual Primary Completion Date :

Sep 17, 2021

Actual Study Completion Date :

Sep 17, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Veterans General Hospital	Kaohsiung City		Taiwan

Sponsors and Collaborators

Sunhawk Vision Biotech, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunhawk Vision Biotech, Inc.

ClinicalTrials.gov Identifier:

NCT04928144

Other Study ID Numbers:

SHJ002-CS201

First Posted:

Jun 16, 2021

Last Update Posted:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sunhawk Vision Biotech, Inc.

Myopia

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Mar 23, 2022