drugset / Trial / NCT04928144
Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2021-07-02
- Primary completion
- 2021-09-17
- Completion
- 2021-09-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SHJ002 | Antisense oligonucleotide | 0.025 % | Topical |
| Subject | SHJ002 | Antisense oligonucleotide | 0.08 % | Topical |
| Subject | SHJ002 | Antisense oligonucleotide | 0.25 % | Topical |