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Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

NCT04928144 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-03-23

No results posted yet for this study

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

Interventions

DRUG

SHJ - Low concentration

Topical ophthalmic

DRUG

SHJ - Mid concentration

Topical ophthalmic

DRUG

SHJ - High concentration

Topical ophthalmic

DRUG

SHJ - Maximum tolerated

SHJ - Maximum tolerated

Sponsors & Collaborators

  • Sunhawk Vision Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Suh-Hang H. Juo, MD, Ph.D. · Sunhawk Vision Biotech, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2021-09-17
Completion
2021-09-17
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928144 on ClinicalTrials.gov