Healthy
Conditions
Brief 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 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.
Interventions
DRUGBT01001 5 mg/ml（0.5%）
BT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule.
DRUGBT01001 10 mg/ml（1.0%）
BT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule.
DRUGBT01001 15 mg/ml（1.5%）
BT01001 Ophthalmic Solution will be administered as topical instillation into the right eye of each subject according to the assigned dosing schedule.
DRUGPlacebo
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.
Sponsors
Beyang Therapeutics Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
\- General Inclusion Criteria: 1. 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. 2. Body Mass Index (BMI) between 18.0 and 27.0 kg/m² (inclusive). 3. Negative alcohol breath test and negative urine drug screen at screening. 4. Willing and able to comply with all study procedure and capable of good communication with study personnel. 5. 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. 6. Able to understand the study procedure and voluntarily sign the written informed consent form. Ophthalmology Inclusion Criteria: 7. Corrected vision acuity ≥ 0.8 in both eyes. 8. Intraocular pressure (IOP) \< 21 mmHg in each eye, with and inter-eye difference \< 4 mmHg. 9. Slit-lamp and ophthalmoscopic examinations that are normal or show abnormalities considered not clinically significant by the investigator.
Exclusion criteria
\- General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as Assessed by CTCAE V5.0 | after dosing up to 14 days/12 days | Any AE event related to study treatment |
| Dose-Limiting Toxicity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measured Area Under the Curve (AUC) | 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; | 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. |
| Time to Maximum Plasma Concentration (Tmax) | 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; | 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. |
| Maximum Plasma Concentration (Cmax) | 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; | 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. |
Countries
China
Outcome results
None listed