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

Staidson (Beijing) Biopharmaceuticals Co., Ltd2 sites in 1 country82 target enrollmentOctober 20, 2024

ConditionsNeurotrophic Keratitis

InterventionsSTSP-0902 ophthalmic solution STSP-0902 Placebo

DrugsSTSP-0902 ophthalmic solution STSP-0902 Placebo

Overview

Phase: Phase 1
Intervention: STSP-0902 ophthalmic solution
Conditions: Neurotrophic Keratitis
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Enrollment: 82
Locations: 2
Primary Endpoint: Incidence of Adverse Events related to study drug
Status: Completed
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 20, 2024

End Date

January 23, 2025

Last Updated

19 days ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male or female subjects aged between 18 and 45 years (inclusive).
•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).
•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.
•Schirmer I test results for both eyes are ≥10 mm/5 minutes (applicable only to subjects in the tear PK study stage).
•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.
•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.
•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

•History or current presence of any eye disease other than refractive errors (e.g., myopia, hyperopia, astigmatism).
•History of any eye surgery (including laser correction surgery) or having only one functional eye.
•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.
•Wearing contact lenses within 2 weeks before screening or needing to wear contact lenses during the clinical study.
•Clinically significant abnormal results from corneal fluorescein staining (applicable only to subjects in the single-dose and multiple-dose study stages).
•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).
•Abnormal and clinically significant results in any of the following tests: Hepatitis B surface antigen, Hepatitis C antibody, syphilis-specific antibody, or HIV test.
•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.
•Vaccination within 1 month prior to screening or planned vaccination during the trial.
•Use of prescription drugs, over-the-counter drugs, or herbal medicines within 2 weeks before screening.