MyopiaPhase 1NCT04928144
Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
A Phase 1 study testing SHJ - Low concentration, SHJ - Mid concentration and SHJ - High concentration in people with Myopia, run by Sunhawk Vision Biotech, Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- SHJ - Low concentration, SHJ - Mid concentration and SHJ - High concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jul 2021to 17 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Myopia
- Being tested
- SHJ - Low concentration, SHJ - Mid concentration, SHJ - High concentration, SHJ - Maximum tolerated
- Keywords
- Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHJ - Low concentrationDrug
Topical ophthalmic
SHJ - Mid concentrationDrug
Topical ophthalmic
SHJ - High concentrationDrug
Topical ophthalmic
SHJ - Maximum toleratedDrug
SHJ - Maximum tolerated
| Study group | Role | What they receive |
|---|---|---|
| 0.025% SHJ002 | Experimental | 0.025% SHJ002 Sterile Ophthalmic Solution Receives: Drug: SHJ - Low concentration |
| 0.080% SHJ002 | Experimental | 0.080% SHJ002 Sterile Ophthalmic Solution Receives: Drug: SHJ - Mid concentration |
| 0.25% SHJ002 | Experimental | 0.25% SHJ002 Sterile Ophthalmic Solution Receives: Drug: SHJ - High concentration |
| SHJ002 - Maximum tolerated concentration | Experimental | Maximum tolerated concentration of SHJ002 Receives: Drug: SHJ - Maximum tolerated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in best corrected visual acuity
Change from baseline in best corrected visual acuity
Measured: 3 days (Part 1) and 28 days (Part 2)
Incidence of Adverse Events
Incidence of Adverse Events
Measured: 3 days (Part 1) and 28 days (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start2 Jul 2021
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Single-center, Open-label, first-in-human dose-escalation.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunhawk Vision Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suh-Hang H. Juo, MD, Ph.D., Study director, Sunhawk Vision Biotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928144
- Sponsor's protocol ID
- SHJ002-CS201
- Status last verified
- Mar 2022
- First submitted
- 9 Jun 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39244490
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intra-subject Dose Escalation Phase 1 Study to Determine the Safety and Tolerability of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT04928144
- Acronym / sponsor ID
- SHJ002-CS201
- Conditions
- Myopia
- Keywords
- Myopia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sunhawk Vision Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Single-center, Open-label, first-in-human dose-escalation.
| Arm | Type | Receives |
|---|---|---|
| 0.025% SHJ002 | Experimental | Drug: SHJ - Low concentration0.025% SHJ002 Sterile Ophthalmic Solution |
| 0.080% SHJ002 | Experimental | Drug: SHJ - Mid concentration0.080% SHJ002 Sterile Ophthalmic Solution |
| 0.25% SHJ002 | Experimental | Drug: SHJ - High concentration0.25% SHJ002 Sterile Ophthalmic Solution |
| SHJ002 - Maximum tolerated concentration | Experimental | Drug: SHJ - Maximum toleratedMaximum tolerated concentration of SHJ002 |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHJ - Low concentrationTopical ophthalmic | Drug | 0.025% SHJ002 |
| SHJ - Mid concentrationTopical ophthalmic | Drug | 0.080% SHJ002 |
| SHJ - High concentrationTopical ophthalmic | Drug | 0.25% SHJ002 |
| SHJ - Maximum toleratedSHJ - Maximum tolerated | Drug | SHJ002 - Maximum tolerated concentration |
Primary outcome
Change from baseline in best corrected visual acuity
Time frame: 3 days (Part 1) and 28 days (Part 2)
Change from baseline in best corrected visual acuity
Incidence of Adverse Events
Time frame: 3 days (Part 1) and 28 days (Part 2)
Incidence of Adverse Events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 39244490Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suh-Hang H. Juo, MD, Ph.D. study director
Sunhawk Vision Biotech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHJ - Low concentration, SHJ - Mid concentration and SHJ - High concentration in people with Myopia, run by Sunhawk Vision Biotech, Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in best corrected visual acuity (time frame: 3 days (Part 1) and 28 days (Part 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04928144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.