A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects

A Phase I, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STSP-0902 Ophthalmic Solution in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Neurotrophic Keratitis
• Intervention / Treatment: Drug: STSP-0902 ophthalmic solution; Drug: STSP-0902 ophthalmic solution; Drug: STSP-0902 ophthalmic solution; Drug: STSP-0902 ophthalmic solution; Drug: STSP-0902 Placebo; Drug: STSP-0902 Placebo

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100005
      • Beijing Tongren Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female subjects aged between 18 and 45 years (inclusive).
2. Male subjects with a weight of ≥50.0 kg, and female subjects with a weight of ≥45.0 kg, with a Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive).
3. Both eyes have a corrected visual acuity of ≥1.0, with normal or clinically insignificant results from eye examinations, including slit-lamp examination, intraocular pressure measurement, and fundus examination.
4. Schirmer I test results for both eyes are ≥10 mm/5 minutes (applicable only to subjects in the tear PK study stage).
5. Physical examination, vital signs, 12-lead ECG, chest imaging, and laboratory tests (including hematology, urinalysis, blood chemistry, and coagulation function) are normal or clinically insignificant during the screening period.
6. Subjects (including their partners) agree to use effective non-drug contraception during the trial and for 6 months after the last dose and must not plan to conceive, donate sperm, or donate eggs.
7. Subjects are fully informed about the content, process, and potential adverse effects of the trial, voluntarily sign the informed consent form, and be willing to complete the trial, follow-up, and related examinations according to the trial plan.

Exclusion Criteria:

1. History or current presence of any eye disease other than refractive errors (e.g., myopia, hyperopia, astigmatism).
2. History of any eye surgery (including laser correction surgery) or having only one functional eye.
3. Use of any topical eye medication (e.g., artificial tears, traditional Chinese medicine eye drops, antibiotic eye drops, recombinant monoclonal antibody eye drops, eye gels, etc.) within 1 month prior to screening.
4. Wearing contact lenses within 2 weeks before screening or needing to wear contact lenses during the clinical study.
5. Clinically significant abnormal results from corneal fluorescein staining (applicable only to subjects in the single-dose and multiple-dose study stages).
6. History or current presence of any severe systemic disease, including but not limited to cardiovascular, cerebrovascular, respiratory, gastrointestinal, endocrine, metabolic, neurological, hematological, oncological, immune, infectious, or psychiatric disorders, especially those that may affect the eyes (e.g., hypertension, diabetes, hyperthyroidism).
7. Abnormal and clinically significant results in any of the following tests: Hepatitis B surface antigen, Hepatitis C antibody, syphilis-specific antibody, or HIV test.
8. Allergy to any component of the investigational product or excipients, history of allergies (especially eye allergies), or a known history of food or drug allergies.
9. Vaccination within 1 month prior to screening or planned vaccination during the trial.
10. Use of prescription drugs, over-the-counter drugs, or herbal medicines within 2 weeks before screening.
11. History of treatment with nerve growth factor (NGF) drugs (e.g., murine NGF) or use of other neurotrophic drugs (e.g., B vitamins, fish oil, etc.) within 3 months before screening.
12. Underwent any major surgery within 6 months prior to screening or has plans for surgery during the trial.
13. History of smoking within 3 months before screening, defined as smoking more than 5 cigarettes or an equivalent amount of tobacco per day on average, or inability to abstain from any tobacco products during the study.
14. Regular alcohol consumption within 6 months before screening, defined as an average daily alcohol intake of more than 2 units (1 unit = 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine), or a positive alcohol breath test result, or inability to abstain from any alcohol products during the study.
15. Daily consumption of more than 5 cups of coffee or strong tea (each cup ≥150 mL) within 3 months before screening, or inability to abstain during the study.
16. History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinol [cannabis], methamphetamine, MDMA [ecstasy], cocaine, etc.) or a positive drug abuse screening result.
17. Blood loss or blood donation >400 mL within 3 months prior to screening, or history of blood transfusion within 4 weeks before screening, or plans to donate blood or blood components during the trial or within 3 months after the trial ends.
18. Participation in any clinical trial and receipt of investigational drugs, devices, or vaccines within 3 months before screening.
19. Pregnant or lactating women, those with a positive blood pregnancy test, or women who have not used effective contraception within 2 weeks before screening.
20. Difficulty in administering eye drops, difficulty with venipuncture, inability to tolerate venipuncture for blood sampling, or history of needle phobia or blood phobia.
21. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Low Dose Arm; Low dose of STSP-0902 ophthalmic solution to study eye. Single dose.	Drug: STSP-0902 ophthalmic solution; Eye drop, single dose; Drug: STSP-0902 ophthalmic solution; Eye drop, three times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, six times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, single dose, tear samples will be collected
Experimental: Single Middle Dose Arm; Middle dose of STSP-0902 ophthalmic solution to study eye. Single dose.	Drug: STSP-0902 ophthalmic solution; Eye drop, single dose; Drug: STSP-0902 ophthalmic solution; Eye drop, three times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, six times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, single dose, tear samples will be collected
Experimental: Single High Dose Arm; High dose of STSP-0902 ophthalmic solution to study eye. Single dose.	Drug: STSP-0902 ophthalmic solution; Eye drop, single dose; Drug: STSP-0902 ophthalmic solution; Eye drop, three times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, six times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, single dose, tear samples will be collected
Experimental: Single Control Dose Arm; STSP-0902 Placebo to study eye. Single dose.	Drug: STSP-0902 Placebo; Eye drop, single dose; Drug: STSP-0902 Placebo; Eye drop, multiple doses
Experimental: Multiple Low Dose Arm; Low dose of STSP-0902 ophthalmic solution to study eye. Three times daily for a total of 8 days.	Drug: STSP-0902 ophthalmic solution; Eye drop, single dose; Drug: STSP-0902 ophthalmic solution; Eye drop, three times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, six times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, single dose, tear samples will be collected
Experimental: Multiple Middle Dose Arm; Middle dose of STSP-0902 ophthalmic solution to study eye. Three times daily for a total of 8 days.	Drug: STSP-0902 ophthalmic solution; Eye drop, single dose; Drug: STSP-0902 ophthalmic solution; Eye drop, three times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, six times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, single dose, tear samples will be collected
Experimental: Multiple High Dose Arm; High dose of STSP-0902 ophthalmic solution to study eye. Three times daily for a total of 8 days.	Drug: STSP-0902 ophthalmic solution; Eye drop, single dose; Drug: STSP-0902 ophthalmic solution; Eye drop, three times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, six times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, single dose, tear samples will be collected
Experimental: Multiple Highest Dose Arm; Middle dose of STSP-0902 ophthalmic solution to study eye. Six times daily for a total of 8 days.	Drug: STSP-0902 ophthalmic solution; Eye drop, single dose; Drug: STSP-0902 ophthalmic solution; Eye drop, three times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, six times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, single dose, tear samples will be collected
Experimental: Multiple Control Dose Arm; STSP-0902 Placebo to study eye. Multiple doses.	Drug: STSP-0902 Placebo; Eye drop, single dose; Drug: STSP-0902 Placebo; Eye drop, multiple doses
Experimental: Tear PK study Arm; STSP-0902 ophthalmic solution to both eyes. Single dose.	Drug: STSP-0902 ophthalmic solution; Eye drop, single dose; Drug: STSP-0902 ophthalmic solution; Eye drop, three times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, six times daily for a total of 8 days; Drug: STSP-0902 ophthalmic solution; Eye drop, single dose, tear samples will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Baseline to Day 28

Collaborators and Investigators

• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Investigators: Principal Investigator: Laichun Lu, Ph.D, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2024
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Subjects; STSP-0902; Ophthalmic Solution
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: STSP-0902-02-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No