AzTrials
AzTrials

Neurotrophic KeratitisPhase 1NCT06597422

A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects

A Phase 1 study testing STSP-0902 ophthalmic solution in people with Neurotrophic Keratitis, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Neurotrophic Keratitis
What is being tested?
STSP-0902 ophthalmic solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
1 siteChina
Study dates
20 Oct 2024to 23 Jan 2025
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 21Show fewer
  • 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.
  • 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.
  • Underwent any major surgery within 6 months prior to screening or has plans for surgery during the trial.
  • 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.
  • 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.
  • 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.
  • History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinol [cannabis], methamphetamine, MDMA [ecstasy], cocaine, etc.) or a positive drug abuse screening result.
  • 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.
  • Participation in any clinical trial and receipt of investigational drugs, devices, or vaccines within 3 months before screening.
  • Pregnant or lactating women, those with a positive blood pregnancy test, or women who have not used effective contraception within 2 weeks before screening.
  • Difficulty in administering eye drops, difficulty with venipuncture, inability to tolerate venipuncture for blood sampling, or history of needle phobia or blood phobia.
  • Any other condition that, in the investigator\'s opinion, makes the subject unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100005

Other trials in China

About this study

Official title: 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.

Being tested
STSP-0902 ophthalmic solution, STSP-0902 Placebo
Keywords
STSP-0902, Ophthalmic Solution, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STSP-0902 ophthalmic solutionDrug

    Eye drop, single dose

  • STSP-0902 PlaceboDrug

    Eye drop, single dose

  • STSP-0902 ophthalmic solutionDrug

    Eye drop, three times daily for a total of 8 days

  • STSP-0902 ophthalmic solutionDrug

    Eye drop, six times daily for a total of 8 days

  • STSP-0902 PlaceboDrug

    Eye drop, multiple doses

  • STSP-0902 ophthalmic solutionDrug

    Eye drop, single dose, tear samples will be collected

Study groups in NCT06597422
Study groupRoleWhat they receive
Single Low Dose ArmExperimentalLow dose of STSP-0902 ophthalmic solution to study eye. Single dose.
Receives: Drug: STSP-0902 ophthalmic solution
Single Middle Dose ArmExperimentalMiddle dose of STSP-0902 ophthalmic solution to study eye. Single dose.
Receives: Drug: STSP-0902 ophthalmic solution
Single High Dose ArmExperimentalHigh dose of STSP-0902 ophthalmic solution to study eye. Single dose.
Receives: Drug: STSP-0902 ophthalmic solution
Single Control Dose ArmExperimentalSTSP-0902 Placebo to study eye. Single dose.
Receives: Drug: STSP-0902 Placebo
Multiple Low Dose ArmExperimentalLow dose of STSP-0902 ophthalmic solution to study eye. Three times daily for a total of 8 days.
Receives: Drug: STSP-0902 ophthalmic solution
Multiple Middle Dose ArmExperimentalMiddle dose of STSP-0902 ophthalmic solution to study eye. Three times daily for a total of 8 days.
Receives: Drug: STSP-0902 ophthalmic solution
Multiple High Dose ArmExperimentalHigh dose of STSP-0902 ophthalmic solution to study eye. Three times daily for a total of 8 days.
Receives: Drug: STSP-0902 ophthalmic solution
Multiple Highest Dose ArmExperimentalMiddle dose of STSP-0902 ophthalmic solution to study eye. Six times daily for a total of 8 days.
Receives: Drug: STSP-0902 ophthalmic solution
Multiple Control Dose ArmExperimentalSTSP-0902 Placebo to study eye. Multiple doses.
Receives: Drug: STSP-0902 Placebo
Tear PK study ArmExperimentalSTSP-0902 ophthalmic solution to both eyes. Single dose.
Receives: Drug: STSP-0902 ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events related to study drug

    Number of participants with ocular and systemic adverse events as assessed by CTCAE v5.0.

    Measured: Baseline to Day 28

Secondary outcomes (2)

  1. STSP-0902 concentration

    Measurement of STSP-0902 in plasma and tear after drug administration

    Measured: Baseline to Day 28

  2. Incidence of positive detection of anti-STSP-0902 antibodies

    Measurement of anti-drug antibody (ADA) to STSP-0902 in plasma after drug administration

    Measured: Baseline to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start20 Oct 2024
  3. Primary completion23 Jan 2025
  4. Study completion23 Jan 2025

Resources

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
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06597422
Sponsor's protocol ID
STSP-0902-02-001
Status last verified
Apr 2026
First submitted
9 Sep 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing STSP-0902 ophthalmic solution in people with Neurotrophic Keratitis, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 1 site in China.

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 7 inclusion and 21 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 13 Apr 2026. 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 China. 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?

Incidence of Adverse Events related to study drug (time frame: Baseline to Day 28). 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 NCT06597422.

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 13 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in