HealthyPhase 1NCT07313722
Study Evaluating Safety of BT01001 Ophthalmic Solution
A Phase 1 study testing BT01001 5 mg/ml（0.5%）, BT01001 10 mg/ml（1.0%） and BT01001 15 mg/ml（1.5%） in people with Healthy, run by Beyang Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This Phase I study is designed to evaluate the safety, tolerability, and pharmacokinetic profile of BT01001 Ophthalmic Solution in healthy adult volunteers. The primary objectives are to assess the safety and tolerability of single and multiple ascending doses and to characterize the pharmacokinetics of BT01001… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BT01001 5 mg/ml（0.5%）, BT01001 10 mg/ml（1.0%） and BT01001 15 mg/ml（1.5%）
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2025to Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- General Inclusion Criteria:
- Healthy male or female participant, 18 to 50 years of age at the time of screening, who are in good health based on medical history, physical examinations, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m² (inclusive).
- Negative alcohol breath test and negative urine drug screen at screening.
- Willing and able to comply with all study procedure and capable of good communication with study personnel.
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- Participants of childbearing potential must agree to abstain from sexual intercourse or use an effective method of contraception from screening until 90 days after the final study drug administration; Female participants of childbearing potential must have a negative urine pregnancy test at screening.
- Able to understand the study procedure and voluntarily sign the written informed consent form.
- Ophthalmology Inclusion Criteria:
- Corrected vision acuity ≥ 0.8 in both eyes.
- Intraocular pressure (IOP) < 21 mmHg in each eye, with and inter-eye difference < 4 mmHg.
- Slit-lamp and ophthalmoscopic examinations that are normal or show abnormalities considered not clinically significant by the investigator.
Who cannot join
- -
- General Exclusion Criteria:
- Known or suspected hypersensitivity to any component of the investigational product, or a history of multiple allergies two or more allergens).
- History or presence of any clinically significant diseases or abnormality, including but not limited to cardiovascular, cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatologic, oncologic, hematologic, immunologic, infectious, neurologic or psychiatric conditions, or any acute or chronic condition that may interfere with study assessments.
- Participation in any investigational drug or medical device trial within 90 days prior to study drug administration.
- Use of prescription or over-the-counter medications within 14 days prior to dosing, or unwillingness to discontinue such medications during the study.
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- Receipt of systemic corticosteroid therapy within 6 months prior to dosing.
- History of alcohol abuse or substance abuse within 2 years prior to dosing.
- Regular smoking of ≥ 5 cigarettes per day (or equivalent tobacco use) within 12 weeks prior to screening, or inability/unwillingness to abstain during the study.
- Average alcohol consumption >14 units per week within 12 weeks prior to screening (1 unit approximately equivalent to 360 mL beer, 150 mL wine, or 45 mL of 40% spirits).
- History or evidence of intravenous illicit drug use; positive test for HIV, HCV, HBsAg, anti-HCV, anti-HIV, or Treponema pallidum antibody at screening.
- Blood donation or receipt of blood products within 30 days prior to dosing.
- History of bleeding disorders or coagulation abnormalities.
- Clinically significant abnormalities on physical examination, vital signs, 12-lead ECG, or laboratory results at screening.
- Abnormal findings that normalize on repeat testing may be accepted if assessed not clinically significant by the investigator.
- Current or past use of bariatric medications or history of bariatric surgery (e.g., gastric bypass).
- Impaired mental status or other factors that may compromise adherence to study requirements.
- Any conditions that, in the investigator's judgment, may interfere with study assessments or pose the participant to unacceptable risks.
- Ophthalmology Exclusion Criteria:
- History of ocular surgery, ocular trauma, or chronic eye disease.
- Current use of contact lenses or use within 2 weeks prior to first dosing.
- Ocular abnormalities or symptoms considered clinically significant by the investigator.
- Use of intraocular injectable or implantable therapies, or topical ophthalmic medications, within 2 months prior to dosing, or expected need during the study.
- History or evidence of ocular e infection, inflammation, blepharitis, or conjunctivitis within 2 months; history of herpes simplex keratitis.
- Clinically significant findings on ophthalmic evaluations (slit lamp, BCVA, IOP, OCT/OCTA, or fundus examination) that, in the investigator's judgment, may interfere with ocular safety evaluations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, 200080
Xueying Ding, MD, 86-13761642319, dingxueying@126.com
Kun Liu, MD, 86-18917989522, drliukun@sjtu.edu.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 0.5%, 1.0%, and 1.5% BT01001 Ophthalmic Solution in Healthy Adult Volunteers
This Phase I study is designed to evaluate the safety, tolerability, and pharmacokinetic profile of BT01001 Ophthalmic Solution in healthy adult volunteers. The primary objectives are to assess the safety and tolerability of single and multiple ascending doses and to characterize the pharmacokinetics of BT01001 Ophthalmic Solution following topical ocular administration.
This is a randomized, double-blind, placebo-controlled, dose-escalation trial consisting of four ascending dose cohorts. Each cohort will enroll eight participants, including six receiving BT01001 Ophthalmic Solution and 2 receiving Placebo.
- Conditions
- Healthy
- Being tested
- BT01001 5 mg/ml（0.5%）, BT01001 10 mg/ml（1.0%）, BT01001 15 mg/ml（1.5%）, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT01001 5 mg/ml（0.5%）Drug
Also called BT01001 Ophthalmic Solution
BT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule.
BT01001 10 mg/ml（1.0%）Drug
Also called BT01001 Ophthalmic Solution
BT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule.
BT01001 15 mg/ml（1.5%）Drug
Also called BT01001 Ophthalmic Solution
BT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule.
PlaceboDrug
Also called BT01001 Ophthalmic Solution Placebo
Placebo BT01001 Ophthalmic Solution will be administered as a topical instillation into the right eye of each subject following the same dosing schedule as the active treatment.
| Study group | Role | What they receive |
|---|---|---|
| BT01001 Ophthalmic Solution dose 1 SAD | Experimental | • BT01001 Ophthalmic Solution 5 mg/ml (0.5%） N = 6 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. Receives: Drug: BT01001 5 mg/ml（0.5%） |
| Placebo dose 1 SAD | Placebo comparator | • Placebo Ophthalmic Solution (0 mg/mL) N = 2 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. Receives: Drug: Placebo |
| BT01001 Ophthalmic Solution dose 1 MAD | Experimental | • BT01001 Ophthalmic Solution 5 mg/ml (0.5%） N = 6 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. Receives: Drug: BT01001 5 mg/ml（0.5%） |
| Placebo dose 1 MAD | Placebo comparator | • Placebo Ophthalmic Solution (0 mg/mL) N = 2 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. Receives: Drug: BT01001 15 mg/ml（1.5%） |
| BT01001 Ophthalmic Solution dose 2 SAD | Experimental | • BT01001 Ophthalmic Solution 10 mg/ml (1.0%） N = 6 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye.
Elution/Washout Phase: 1 day following SAD. Receives: Drug: BT01001 10 mg/ml（1.0%） |
| Placebo dose 2 SAD | Placebo comparator | • Placebo Ophthalmic Solution (0 mg/mL) N = 2 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. Receives: Drug: Placebo |
| BT01001 Ophthalmic Solution dose 2 MAD | Experimental | • BT01001 Ophthalmic Solution 10 mg/ml (1.0%） N = 6 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. Receives: Drug: BT01001 10 mg/ml（1.0%） |
| Placebo dose 2 MAD | Placebo comparator | • Placebo Ophthalmic Solution (0 mg/mL) N = 2 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. Receives: Drug: Placebo |
| BT01001 Ophthalmic Solution dose 3 SAD | Experimental | • BT01001 Ophthalmic Solution 15 mg/ml (1.5%） N = 6 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye.
Elution/Washout Phase: 1 day following SAD. Receives: Drug: BT01001 15 mg/ml（1.5%） |
| Placebo dose 3 SAD | Placebo comparator | • Placebo Ophthalmic Solution (0 mg/mL) N = 2 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. Receives: Drug: Placebo |
| BT01001 Ophthalmic Solution dose 3 MAD | Experimental | • BT01001 Ophthalmic Solution 15 mg/ml (1.5%） N = 6 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. Receives: Drug: BT01001 15 mg/ml（1.5%） |
| Placebo dose 3 MAD | Placebo comparator | • Placebo Ophthalmic Solution (0 mg/mL) N = 2 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. Receives: Drug: Placebo |
| BT01001 Ophthalmic Solution dose 4 MAD | Experimental | • BT01001 Ophthalmic Solution 15 mg/ml (1.5%） N = 6 Multiple Ascending Dose (MAD, Days 1-7): 2 drops administered three times daily (TID) from Days 1 to 6; on Day 7, 2 drops administered once in the morning only to the right eye.
Dose Administration: 2 drops with three minutes interval per dosing time. Receives: Drug: BT01001 15 mg/ml（1.5%） |
| Placebo dose 4 MAD | Placebo comparator | • Placebo Ophthalmic Solution (0 mg/mL) N = 2 Multiple Ascending Dose (MAD, Days 1-7): 2 drops administered three times daily (TID) from Days 1 to 6; on Day 7, 2 drops administered once in the morning only to the right eye.
Dose Administration: 2 drops with three minutes interval per dosing time. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as Assessed by CTCAE V5.0
Any AE event related to study treatment
Measured: after dosing up to 14 days/12 days
Dose-Limiting Toxicity
≥CTCAE 2 ocular adverse events or· >CTCAE 3 non-ocular· adverse events· assessed with·CTCAE·5.0
Measured: SAD: after dosing up to 2 days; MAD: after dosing up to 8 days
Secondary outcomes (3)
Measured Area Under the Curve (AUC)
SAD(dose 1-3): at Day 1 pre-dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h.
MAD(dose 1-3): at Day 8 pre-dose(before the first dose), Day 8 pre-dose(before the second dose), Day 9 pre-dose(before the first drop), 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h.
MAD(dose 4): at Day 6 pre-dose(before the second dose), Day 6 pre-dose(before the third dose), Day 7 pre-dose(before the first dose), 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h.
Measured: SAD(dose 1-3): Day 1, Day 2; MAD(dose 1-3): Day 8, Day 9, Day 10; MAD(dose 4): Day 6, Day 7,Day 8;
Time to Maximum Plasma Concentration (Tmax)
SAD(dose 1-3): at Day 1 pre-dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h.
MAD(dose 1-3): at Day 8 pre-dose(before the first dose), Day 8 pre-dose(before the second dose), Day 9 pre-dose(before the first drop), 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h.
MAD(dose 4): at Day 6 pre-dose(before the second dose), Day 6 pre-dose(before the third dose), Day 7 pre-dose(before the first dose), 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h.
Measured: SAD(dose 1-3): Day 1, Day 2; MAD(dose 1-3): Day 8, Day 9, Day 10; MAD(dose 4): Day 6, Day 7,Day 8;
Maximum Plasma Concentration (Cmax)
SAD(dose 1-3): at Day 1 pre-dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h.
MAD(dose 1-3): at Day 8 pre-dose(before the first dose), Day 8 pre-dose(before the second dose), Day 9 pre-dose(before the first drop), 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h.
MAD(dose 4): at Day 6 pre-dose(before the second dose), Day 6 pre-dose(before the third dose), Day 7 pre-dose(before the first dose), 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h.
Measured: SAD(dose 1-3): Day 1, Day 2; MAD(dose 1-3): Day 8, Day 9, Day 10; MAD(dose 4): Day 6, Day 7,Day 8;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start17 Nov 2025
- Primary completionFeb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beyang Therapeutics Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313722
- Sponsor's protocol ID
- BT01001-101
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 0.5%, 1.0%, and 1.5% BT01001 Ophthalmic Solution in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07313722
- Acronym / sponsor ID
- BT01001-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Beyang Therapeutics Co., Ltd.University, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 2 Jan 2026 (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 Phase I study is designed to evaluate the safety, tolerability, and pharmacokinetic profile of BT01001 Ophthalmic Solution in healthy adult volunteers. The primary objectives are to assess the safety and tolerability of single and multiple ascending doses and to characterize the pharmacokinetics of BT01001 Ophthalmic Solution following topical ocular administration.
This is a randomized, double-blind, placebo-controlled, dose-escalation trial consisting of four ascending dose cohorts. Each cohort will enroll eight participants, including six receiving BT01001 Ophthalmic Solution and 2 receiving Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| BT01001 Ophthalmic Solution dose 1 SAD | Experimental | Drug: BT01001 5 mg/ml（0.5%）• BT01001 Ophthalmic Solution 5 mg/ml (0.5%） N = 6 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. |
| Placebo dose 1 SAD | Placebo comparator | Drug: Placebo• Placebo Ophthalmic Solution (0 mg/mL) N = 2 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. |
| BT01001 Ophthalmic Solution dose 1 MAD | Experimental | Drug: BT01001 5 mg/ml（0.5%）• BT01001 Ophthalmic Solution 5 mg/ml (0.5%） N = 6 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. |
| Placebo dose 1 MAD | Placebo comparator | Drug: BT01001 15 mg/ml（1.5%）• Placebo Ophthalmic Solution (0 mg/mL) N = 2 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. |
| BT01001 Ophthalmic Solution dose 2 SAD | Experimental | Drug: BT01001 10 mg/ml（1.0%）• BT01001 Ophthalmic Solution 10 mg/ml (1.0%） N = 6 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. |
| Placebo dose 2 SAD | Placebo comparator | Drug: Placebo• Placebo Ophthalmic Solution (0 mg/mL) N = 2 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. |
| BT01001 Ophthalmic Solution dose 2 MAD | Experimental | Drug: BT01001 10 mg/ml（1.0%）• BT01001 Ophthalmic Solution 10 mg/ml (1.0%） N = 6 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. |
| Placebo dose 2 MAD | Placebo comparator | Drug: Placebo• Placebo Ophthalmic Solution (0 mg/mL) N = 2 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. |
| BT01001 Ophthalmic Solution dose 3 SAD | Experimental | Drug: BT01001 15 mg/ml（1.5%）• BT01001 Ophthalmic Solution 15 mg/ml (1.5%） N = 6 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. |
| Placebo dose 3 SAD | Placebo comparator | Drug: Placebo• Placebo Ophthalmic Solution (0 mg/mL) N = 2 Single Ascending Dose (SAD, Day 1): 2 drops administered once to the right eye. Elution/Washout Phase: 1 day following SAD. |
| BT01001 Ophthalmic Solution dose 3 MAD | Experimental | Drug: BT01001 15 mg/ml（1.5%）• BT01001 Ophthalmic Solution 15 mg/ml (1.5%） N = 6 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. |
| Placebo dose 3 MAD | Placebo comparator | Drug: Placebo• Placebo Ophthalmic Solution (0 mg/mL) N = 2 Multiple Ascending Dose (MAD, Days 3-9): 2 drops administered twice daily (BID) from Days 3 to 8; on Day 9, 2 drops administered once in the morning only. Dose Administration: 2 drops with three minutes interval per dosing time. |
| BT01001 Ophthalmic Solution dose 4 MAD | Experimental | Drug: BT01001 15 mg/ml（1.5%）• BT01001 Ophthalmic Solution 15 mg/ml (1.5%） N = 6 Multiple Ascending Dose (MAD, Days 1-7): 2 drops administered three times daily (TID) from Days 1 to 6; on Day 7, 2 drops administered once in the morning only to the right eye. Dose Administration: 2 drops with three minutes interval per dosing time. |
| Placebo dose 4 MAD | Placebo comparator | Drug: Placebo• Placebo Ophthalmic Solution (0 mg/mL) N = 2 Multiple Ascending Dose (MAD, Days 1-7): 2 drops administered three times daily (TID) from Days 1 to 6; on Day 7, 2 drops administered once in the morning only to the right eye. Dose Administration: 2 drops with three minutes interval per dosing time. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- -
- Healthy male or female participant, 18 to 50 years of age at the time of screening, who are in good health based on medical history, physical examinations, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m² (inclusive).
- Negative alcohol breath test and negative urine drug screen at screening.
- Willing and able to comply with all study procedure and capable of good communication with study personnel.
Key exclusion criteria (25 listed)
- -
- Known or suspected hypersensitivity to any component of the investigational product, or a history of multiple allergies two or more allergens).
- History or presence of any clinically significant diseases or abnormality, including but not limited to cardiovascular, cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatologic, oncologic, hematologic, immunologic, infectious, neurologic or psychiatric conditions, or any acute or chronic condition that may interfere with study assessments.
- Participation in any investigational drug or medical device trial within 90 days prior to study drug administration.
- Use of prescription or over-the-counter medications within 14 days prior to dosing, or unwillingness to discontinue such medications during the 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 |
|---|---|---|
| BT01001 5 mg/ml（0.5%）Also: BT01001 Ophthalmic SolutionBT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule. | Drug | BT01001 Ophthalmic Solution dose 1 MAD, BT01001 Ophthalmic Solution dose 1 SAD |
| BT01001 10 mg/ml（1.0%）Also: BT01001 Ophthalmic SolutionBT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule. | Drug | BT01001 Ophthalmic Solution dose 2 MAD, BT01001 Ophthalmic Solution dose 2 SAD |
| BT01001 15 mg/ml（1.5%）Also: BT01001 Ophthalmic SolutionBT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule. | Drug | BT01001 Ophthalmic Solution dose 3 MAD, BT01001 Ophthalmic Solution dose 3 SAD, BT01001 Ophthalmic Solution dose 4 MAD, Placebo dose 1 MAD |
| PlaceboAlso: BT01001 Ophthalmic Solution PlaceboPlacebo BT01001 Ophthalmic Solution will be administered as a topical instillation into the right eye of each subject following the same dosing schedule as the active treatment. | Drug | Placebo dose 1 SAD, Placebo dose 2 MAD, Placebo dose 2 SAD, Placebo dose 3 MAD, Placebo dose 3 SAD, Placebo dose 4 MAD |
Primary outcome
Number of Participants With Adverse Events as Assessed by CTCAE V5.0
Time frame: after dosing up to 14 days/12 days
Any AE event related to study treatment
Dose-Limiting Toxicity
Time frame: SAD: after dosing up to 2 days; MAD: after dosing up to 8 days
≥CTCAE 2 ocular adverse events or· >CTCAE 3 non-ocular· adverse events· assessed with·CTCAE·5.0
3 secondary outcomes
Measured Area Under the Curve (AUC)
Time frame: SAD(dose 1-3): Day 1, Day 2; MAD(dose 1-3): Day 8, Day 9, Day 10; MAD(dose 4): Day 6, Day 7,Day 8;
Time to Maximum Plasma Concentration (Tmax)
Time frame: SAD(dose 1-3): Day 1, Day 2; MAD(dose 1-3): Day 8, Day 9, Day 10; MAD(dose 4): Day 6, Day 7,Day 8;
Maximum Plasma Concentration (Cmax)
Time frame: SAD(dose 1-3): Day 1, Day 2; MAD(dose 1-3): Day 8, Day 9, Day 10; MAD(dose 4): Day 6, Day 7,Day 8;
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BT01001 5 mg/ml（0.5%）, BT01001 10 mg/ml（1.0%） and BT01001 15 mg/ml（1.5%） in people with Healthy, run by Beyang Therapeutics 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 25 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: looking for participants now, as of the sponsor's last update on 2 Jan 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events as Assessed by CTCAE V5.0 (time frame: after dosing up to 14 days/12 days). The study lists 2 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 2 Jan 2026.