NCT05456724进行中（未招募）1 期
A 3-Part, First-in-human, Double-Blind, Randomized, and Placebo-Controlled Study Assessing the Safety, Tolerability, and Efficacy of TO-O-1001 Ophthalmic Solution in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension
Theratocular Biotek Co.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety and tolerability of TO-O-1001 though the incidence of adverse events.
研究概览
简要总结
This is a Phase I/II stage to investigate the safety, tolerability, and ocular hypotensive efficacy of TO-O-1001 in healthy volunteers and patients with Open-Angle Glaucoma or Ocular Hypertension.
The proposed trial consists of 3 study parts to be conducted at Nucleus Network Melbourne.
This study will enroll up to 34 evaluable healthy volunteers in part 1(SAD) and part 2(MD) and 16 evaluable patients with Open-Angle Glaucoma or Ocular Hypertension in part 3(MD).
Note- As of 14Mar2023, enrolment has been completed for Part 1 and Part 2 and recruitment is pending now for Part 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Healthy Subjects (Parts 1 & 2)
- •18 - 59-year-old healthy male or female subjects who are non-lactating and non-pregnant.
- •BMI 18.0~32.0(kg/m2) and body weight more than 45kg.
- •Intraocular pressure between 10 - 21 mm Hg (inclusive) in each eye.
- •Best-corrected visual acuity (BCVA) in each eye of 20/40 ETRDS or better.
- •The informed consent form has been read, signed and dated by the subjects.
- •Able to communicate well with the investigator and comply with the requirements of the study.
- •For Patients (Part 3)
- •Must be 18 years of age or older.
- •Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT).
- •Unmedicated or after washout intraocular pressure (IOP) >20 mmHg and < 30 mmHg in study eye at T0 (T0 = 08:00AM~10:00 AM) of the first qualification visit (Day 1).
- •Best-corrected visual acuity (BCVA) equivalent to 20/200 ETRDS or better.
- •The informed consent form has been read, signed and dated by the subjects.
- •Able to communicate well with the investigator and comply with the requirements of the study
排除标准
- •For Healthy Subjects (Parts 1 & 2)
- •Subjects has chronic or acute ophthalmic disease including glaucoma, macular degeneration, and clinically significant cataract (primary or secondary).
- •Subjects has previous glaucoma intraocular surgery or glaucoma laser procedures within 3 years.
- •Subjects has refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) within 5 years.
- •Subjects has ocular trauma within the past 6 months, or ocular surgery or laser treatment within the past three months (e.g., laser treatment for glaucoma or retina).
- •For Patients (Part 3)
- •Closed or very narrow angles (Grade 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening Visit in either eye. (Patent laser iridotomy with Grade 1-2 angles is acceptable in either eye, providing the PAS criteria are still met).
- •Previous glaucoma intraocular surgery in either eye. Prior laser trabeculoplasty (ALT or SLT) in either eye is allowed if performed more than 6 months prior to Screening Visit.
- •Any non-glaucoma intraocular surgery within 3 months prior to Screening Visit in either eye.
- •Participation in a clinical study with use of any investigational drug or treatment within 28 days prior to Baseline (Day 1).
- •Clinically significant abnormalities in: laboratory tests, physical examination, vital signs and/or ECG at Screening Visit. If in the investigator's judgment a subjects with clinically significant abnormalities is appropriate for enrollment in the study, a discussion between the investigator and the Medical Monitor must occur and be documented prior to enrollment of this subjects in the study.
研究组 & 干预措施
A (TO-O-1001)
Experimental
Drug: TO-O-1001 Dose level: 0.05% and 0.1% Dosage form: ophthalmic solution Route of administration: topical ocular
干预措施: TO-O-1001 (Drug)
B (Placebo)
Placebo Comparator
Dosage form: ophthalmic solution Route of administration: topical ocular
干预措施: Placebo (Other)
结局指标
主要结局
Safety and tolerability of TO-O-1001 though the incidence of adverse events.
时间窗: Up to 28 days
Number of participants with treatment-emergent adverse events (AEs).
Evaluate the ocular hypotensive efficacy of TO-O-1001 through Goldmann Applanation Tonometry.
时间窗: Up to 28 days
The primary efficacy outcome is mean IOP.
次要结局
- Pharmacokinetics of TO-O-1001. Blood samples obtained to evaluate the systemic exposure.(Up to 8 days)
- Best Corrected Visual Acuity (BCVA) of TO-O-1001.(Up to 28 days)
- Safety and tolerability of TO-O-1001 through the incidence, severity and causality of serious adverse events (SAEs).(Up to 28 days)
研究者
研究点 (1)
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