Status and phase
Conditions
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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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.
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.
Exclusion criteria
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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.
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.
Primary purpose
Allocation
Interventional model
Masking
32 participants in 14 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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