BlepharoptosisEarly Phase 1NCT06911216
A Pharmacokinetics (PK) Study in Healthy Adults
A Early Phase 1 study testing STN1013800 ophthalmic solution in people with Blepharoptosis, run by Santen Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is to characterize STN1013800 active ingredient bioavailability following multiple-dose ocular administration of STN1013800 to both eyes in healthy adults. It is a PK study with screening period of up to 28 days + dosing period of 7 days + Follow-up period of 2 days. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blepharoptosis
- What is being tested?
- STN1013800 ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2025to 7 Apr 2025
- Phase
- Early 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
- Must be able to understand and sign the informed consent form approved by the independent ethics committee.
- Age: 18～45 years old; male and female genders.
- Best corrected visual acuity≥1.0 with no diagnosed ocular or rheumatologic disorders (e.g. dry eyes) that may affect vision.
- Current non-smokers who have not used tobacco or nicotine in any form (including non-nicotine vaping/electronic cigarette products) at least 6 months prior to Day -1.
- Weigh at least 50 kg and have a standard Body Mass Index (BMI) (19-24, Boundary containing value) at the time of screening.
- Female volunteers, for pregnancy avoidance/prevention, the subject should be sterile, postmenopausal or approved methods of contraception.
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- Male volunteers for pregnancy avoidance/prevention of subject's female partner (if any), the subject should be sterile, not sexually active, or using approved methods of contraception.
- Judged by the Investigator to be healthy based on the medical history and screening procedures (physical examination, 12-lead ECG, vital signs, and laboratory test results)
- Negative test for selected drugs of abuse, cotinine and alcohol at the Screening visit and on Day -1.
- Negative serum hepatitis panel, negative Human Immunodeficiency Virus (HIV), and treponema pallidum antibody tests at the Screening visit.
- Negative pregnancy test for females of childbearing potential at the Screening visit and on Day -1.
- Understands the study requirements and willing to participate in the study.
Who cannot join
- Participation in any other investigational study drug trial in which receipt of an investigational study drug or device occurred within 30 days prior to Day -1.
- Contact lenses wearing during dose administration.
- Use of any over-the-counter (OTC), non-prescription preparations (including multivitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within the 14 days or 5 half-lives, whichever is longer, prior to Day -1.
- Use of any prescription medications within the 14 days or 5 half-lives, whichever is longer prior to Day -1.
- History or presence of any significant metabolic, allergic, cardiovascular, pulmonary, hepatic, renal, hematologic (including bleeding disorders), gastrointestinal (including peptic ulcer disease, gastritis or bleeding diathesis, excluding appendectomy or hernia repair), endocrine, immunologic, dermatologic, muscular, genitourinary, neurological, ophthalmologic, psychiatric, neoplastic, or other disease, that, in the opinion of the investigator, could interfere with the course of the study or expose the subject to undue risk by participating in this study.
- Known hypersensitivity or idiosyncratic reaction to oxymetazoline or any related products (including excipients of the formulation) as well as severe hypersensitivity to any drugs.
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- History of cancer within the past 5 years, except for basal cell carcinoma with documentation of a 6-month remission at the Screening visit.
- Any clinically significant illness in the previous 28 days before Day-1.
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before Day-1.
- Current use of a beta blocker or tricyclic antidepressant.
- Any history of ocular hypertension or glaucoma; heart disease, angina, arteriosclerotic disease, or irregular heartbeat; hyperthyroidism; diabetes mellitus; poor peripheral venous access.
- Any history of tuberculosis and/or prophylaxis for tuberculosis.
- Urinary hesitancy or retention from prostatic hypertrophy.
- Receipt or donation of any blood products within 3 months prior to Day-1.
- History or presence of alcoholism or drug abuse or dependence (addiction), as determined at the discretion of the Investigator, within the past 2 years.
- Seated (after at least 5 minutes in a sitting position) systolic blood pressure >140 mmHg or <90 mmHg or a diastolic blood pressure >90 mmHg at the Screening visit (blood pressure may be re-tested up to twice in the seated position at intervals of at least 5 minutes; the pressure elevation is considered sustained if either the systolic or diastolic pressure exceeds the states limits after 3 assessments).
- Pulse rate at rest (after at least 5 minutes in a sitting position) of <60 bpm or >100 bpm at the Screening visit.
- History of clinically significant abnormal ECG findings or a Screening ECG including but not limited to a second- or third-degree AV; QRS >120 milliseconds (msec); QTcF >450 msec for males or QTcF >470 msec for females; PR interval >240 msec; or any rhythm other than normal sinus rhythm that is deemed clinically significant by the Investigator.
- Hospitalization during the 3 months prior to the Screening visit except for minor scheduled outpatient procedures.
- In the Investigator's opinion, have been on an abnormal diet (for whatever reason) during the 28 days prior to Day-1.
- For male subjects: intent to donate sperm from the first drug administration until 30 days after the last dose administration.
- Any acute or chronic medical or psychiatric condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study.
- Periocular neurotoxin (e.g., Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to Day -1 and during the study.
- Taken any monoamine oxidase inhibitor (MAOIs) (e.g., isocarboxazid, phenelzine, tranylcypromine) within 14 days prior to Day-1 and during the study.
- Topical application of bimatoprost (i.e., Latisse®) to the eyelashes within 7 days prior to Day-1 and during the study.
- Topical ophthalmic medications (including but not limited to anti-allergy [e.g., antihistamines], dry eye [i.e.,Restasis®, Xiidra®], antimicrobial drugs [e.g., antibiotics and antivirals], and anti-inflammatory drugs [including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids] other than the assigned study medication within 7 days prior Day-1 and during the study. All topical antiglaucoma medications are prohibited.
- Intravitreal injections (e.g., Lucentis®, Eylea®, Avastin®, Triesence®) within 7 days prior to Screening visit and during the study.
- Current punctal plugs or placement of punctal plugs during the study.
- Use of any OTC vasoconstrictor/decongestant eye medication (e.g., Visine® L.R.®) or any ophthalmic or non-ophthalmic α-adrenergic agonist including OTC products (e.g., Afrin®) within 7 days prior Day-1 and during the study. Artificial tears are allowed up to 24 hours prior to first drug administration.
- Any consistent or intermittent use of oxymetazoline containing medications, including oxymetazoline nasal spray or oral products within 30 days prior to Screening visit and during study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-Dose Pharmacokinetics (PK) Study of STN1013800 in Healthy Adults
This is to characterize STN1013800 active ingredient bioavailability following multiple-dose ocular administration of STN1013800 to both eyes in healthy adults.
It is a PK study with screening period of up to 28 days + dosing period of 7 days + Follow-up period of 2 days.
At present, there are no medicines for the treatment of acquired blepharoptosis in China.
Therefore, efficacy and safety phase III study is also currently being conducted.
- Conditions
- Blepharoptosis
- Being tested
- STN1013800 ophthalmic solution
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN1013800 ophthalmic solutionDrug
Investigational Product: 0.1% STN1013800 ophthalmic solution once daily (QD) (9AM ± 60 min), one drop for each eye
| Study group | Role | What they receive |
|---|---|---|
| STN1013800 ophthalmic solution | Experimental | 0.1% STN1013800 ophthalmic solution administered once daily (QD) for 7 days Receives: Drug: STN1013800 ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK (Pharmacokinetic) parameter to measure: Cmax
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Cmax - Peak concentration
Measured: Day 1, 5, 6, and 7
PK parameter to measure: Cmin
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Cmin - Minimum concentration
Measured: Day 1, 5, 6, and 7
PK parameter to measure: Tmax
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Tmax - Peak time
Measured: Day 1, 5, 6, and 7
PK parameter to measure: AUC0-24h
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUC0-24h - The area under the drug-time curve for the quantifiable time period from 0 to 24 hours after drug administration.
Measured: Day 1, 5, 6, and 7
PK parameter to measure: AUC0-36h
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUC0-36h - The area under the drug-time curve from 0 to 36 hours after drug administration
Measured: Day 1, 5, 6, and 7
PK parameter to measure: AUCinf
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUCinf - The area under the drug-time curve from 0 to infinity after drug administration
Measured: Day 1, 5, 6, and 7
PK parameter to measure: kel
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. kel - Elimination rate constant. The negative of the slope value obtained by taking the logarithm of the plasma concentration in the vanishing phase of the time curve and performing linear regression on time obtained.
Measured: Day 1, 5, 6, and 7
PK parameter to measure: t½
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. t½ - Elimination half-life
Measured: Day 1, 5, 6, and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start17 Mar 2025
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911216
- Sponsor's protocol ID
- 101380004CN
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose Pharmacokinetics (PK) Study of STN1013800 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06911216
- Acronym / sponsor ID
- 101380004CN
- Conditions
- Blepharoptosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is to characterize STN1013800 active ingredient bioavailability following multiple-dose ocular administration of STN1013800 to both eyes in healthy adults.
It is a PK study with screening period of up to 28 days + dosing period of 7 days + Follow-up period of 2 days.
At present, there are no medicines for the treatment of acquired blepharoptosis in China.
Therefore, efficacy and safety phase III study is also currently being conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STN1013800 ophthalmic solution | Experimental | Drug: STN1013800 ophthalmic solution0.1% STN1013800 ophthalmic solution administered once daily (QD) for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Must be able to understand and sign the informed consent form approved by the independent ethics committee.
- Age: 18～45 years old; male and female genders.
- Best corrected visual acuity≥1.0 with no diagnosed ocular or rheumatologic disorders (e.g. dry eyes) that may affect vision.
- Current non-smokers who have not used tobacco or nicotine in any form (including non-nicotine vaping/electronic cigarette products) at least 6 months prior to Day -1.
- Weigh at least 50 kg and have a standard Body Mass Index (BMI) (19-24, Boundary containing value) at the time of screening.
Key exclusion criteria (30 listed)
- Participation in any other investigational study drug trial in which receipt of an investigational study drug or device occurred within 30 days prior to Day -1.
- Contact lenses wearing during dose administration.
- Use of any over-the-counter (OTC), non-prescription preparations (including multivitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within the 14 days or 5 half-lives, whichever is longer, prior to Day -1.
- Use of any prescription medications within the 14 days or 5 half-lives, whichever is longer prior to Day -1.
- History or presence of any significant metabolic, allergic, cardiovascular, pulmonary, hepatic, renal, hematologic (including bleeding disorders), gastrointestinal (including peptic ulcer disease, gastritis or bleeding diathesis, excluding appendectomy or hernia repair), endocrine, immunologic, dermatologic, muscular, genitourinary, neurological, ophthalmologic, psychiatric, neoplastic, or other disease, that, in the opinion of the investigator, could interfere with the course of the study or expose the subject to undue risk by participating in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STN1013800 ophthalmic solutionInvestigational Product: 0.1% STN1013800 ophthalmic solution once daily (QD) (9AM ± 60 min), one drop for each eye | Drug | STN1013800 ophthalmic solution |
Primary outcome
PK (Pharmacokinetic) parameter to measure: Cmax
Time frame: Day 1, 5, 6, and 7
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Cmax - Peak concentration
PK parameter to measure: Cmin
Time frame: Day 1, 5, 6, and 7
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Cmin - Minimum concentration
PK parameter to measure: Tmax
Time frame: Day 1, 5, 6, and 7
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. Tmax - Peak time
PK parameter to measure: AUC0-24h
Time frame: Day 1, 5, 6, and 7
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUC0-24h - The area under the drug-time curve for the quantifiable time period from 0 to 24 hours after drug administration.
PK parameter to measure: AUC0-36h
Time frame: Day 1, 5, 6, and 7
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUC0-36h - The area under the drug-time curve from 0 to 36 hours after drug administration
PK parameter to measure: AUCinf
Time frame: Day 1, 5, 6, and 7
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. AUCinf - The area under the drug-time curve from 0 to infinity after drug administration
PK parameter to measure: kel
Time frame: Day 1, 5, 6, and 7
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. kel - Elimination rate constant. The negative of the slope value obtained by taking the logarithm of the plasma concentration in the vanishing phase of the time curve and performing linear regression on time obtained.
PK parameter to measure: t½
Time frame: Day 1, 5, 6, and 7
Blood samples will be collected on Day 1, Day 5, Day 6, and Day 7. t½ - Elimination half-life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing STN1013800 ophthalmic solution in people with Blepharoptosis, run by Santen Pharmaceutical 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 12 inclusion and 30 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 22 Apr 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
PK (Pharmacokinetic) parameter to measure: Cmax (time frame: Day 1, 5, 6, and 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2025.