Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of STSP-0902 ophthalmic solution in healthy subjects following single and multiple administrations. The study plans to enroll 80 healthy subjects and is divided into three stages: the single-dose study stage, the multiple-dose study stage, and the tear PK study stage. The single-dose and multiple-dose study stages are randomized, double-blind, placebo-controlled, dose-escalation designs, while the tear PK study stage is a single-dose, open-label design.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Low Dose Arm | Experimental | Low dose of STSP-0902 ophthalmic solution to study eye. Single dose. |
|
| Single Middle Dose Arm | Experimental | Middle dose of STSP-0902 ophthalmic solution to study eye. Single dose. |
|
| Single High Dose Arm | Experimental | High dose of STSP-0902 ophthalmic solution to study eye. Single dose. |
|
| Single Control Dose Arm | Experimental | STSP-0902 Placebo to study eye. Single dose. |
|
| Multiple Low Dose Arm | Experimental | Low dose of STSP-0902 ophthalmic solution to study eye. Three times daily for a total of 8 days. |
|
| Multiple Middle Dose Arm | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSP-0902 ophthalmic solution | Drug | Eye drop, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events related to study drug | Number of participants with ocular and systemic adverse events as assessed by CTCAE v5.0. | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| STSP-0902 concentration | Measurement of STSP-0902 in plasma and tear after drug administration | Baseline to Day 28 |
| Incidence of positive detection of anti-STSP-0902 antibodies | Measurement of anti-drug antibody (ADA) to STSP-0902 in plasma after drug administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laichun Lu, Ph.D | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100005 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Middle dose of STSP-0902 ophthalmic solution to study eye. Three times daily for a total of 8 days.
|
| Multiple High Dose Arm | Experimental | High dose of STSP-0902 ophthalmic solution to study eye. Three times daily for a total of 8 days. |
|
| Multiple Highest Dose Arm | Experimental | Middle dose of STSP-0902 ophthalmic solution to study eye. Six times daily for a total of 8 days. |
|
| Multiple Control Dose Arm | Experimental | STSP-0902 Placebo to study eye. Multiple doses. |
|
| Tear PK study Arm | Experimental | STSP-0902 ophthalmic solution to both eyes. Single dose. |
|
| STSP-0902 Placebo | Drug | Eye drop, single dose |
|
| STSP-0902 ophthalmic solution | Drug | Eye drop, three times daily for a total of 8 days |
|
| STSP-0902 ophthalmic solution | Drug | Eye drop, six times daily for a total of 8 days |
|
| STSP-0902 Placebo | Drug | Eye drop, multiple doses |
|
| STSP-0902 ophthalmic solution | Drug | Eye drop, single dose, tear samples will be collected |
|
| Baseline to Day 28 |