Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

NCT04928144 | Completed Phase 1 FDA Drug

• 1 other identifier: SHJ002-CS201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Myopia

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (4)

0.025% SHJ002

EXPERIMENTAL

0.025% SHJ002 Sterile Ophthalmic Solution

Drug: SHJ - Low concentration

0.080% SHJ002

EXPERIMENTAL

0.080% SHJ002 Sterile Ophthalmic Solution

Drug: SHJ - Mid concentration

0.25% SHJ002

EXPERIMENTAL

0.25% SHJ002 Sterile Ophthalmic Solution

Drug: SHJ - High concentration

SHJ002 - Maximum tolerated concentration

EXPERIMENTAL

Maximum tolerated concentration of SHJ002

Drug: SHJ - Maximum tolerated

Interventions

SHJ - Low concentration DRUG

Topical ophthalmic

0.025% SHJ002

SHJ - Mid concentration DRUG

Topical ophthalmic

0.080% SHJ002

SHJ - High concentration DRUG

Topical ophthalmic

0.25% SHJ002

SHJ - Maximum tolerated DRUG

SHJ - Maximum tolerated

SHJ002 - Maximum tolerated concentration

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunhawk Vision Biotech, Inc.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Related Publications (1)

• Chen JL, Lai WY, Lin RT, Juo SH, Liang CL. Safety and Tolerability of Anti-microRNA-328 Ophthalmic Solution, SHJ002, in Pediatric Subjects: First-in-Human Clinical Study. Clin Ther. 2024 Oct;46(10):768-772. doi: 10.1016/j.clinthera.2024.08.015. Epub 2024 Sep 7.

  PMID: 39244490 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Suh-Hang H. Juo, MD, Ph.D.

  Sunhawk Vision Biotech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: July 2, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)