A Phase 1, Double-Masked, Placebo-Controlled, Dose-Escalation Study (in Two Parts) of TG100801 and a Colored Vehicle in Adult Healthy Volunteers
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Macular Degeneration
- 发起方
- TargeGen
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Part A: Safety & tolerability of vehicle & 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 1 day, assessed up to 5 (+/- 1) days following dosing.
- 状态
- 已完成
- 最后更新
- 18年前
概览
简要总结
The formation of new blood vessels (angiogenesis), blood vessel leakage, and inflammation contribute to the progression of the eye disease, age-related macular degeneration (AMD), which is the leading cause of irreversible, severe loss of vision in people 55 years of age and older in the developed world. TG100801 is a new drug that inhibits ocular angiogenesis, vascular leak, and inflammation in laboratory studies, and may have great utility in the treatment of diseases such as AMD.
The purpose of this study is to assess the safety, ocular tolerability, and blood pharmacokinetics of TG100801 at escalating doses in healthy volunteers.
研究者
入排标准
入选标准
- •Male or female healthy volunteers who meet the following criteria are eligible for inclusion in the study. Subjects who participate in Part A of the study may not participate in Part B.
- •Age \> 18 years (50% of subjects must be \> 40 years of age).
- •Corrected visual acuity \> 20/25 in both eyes.
- •Intraocular pressure (IOP) \< 21 mm Hg, with a difference between eyes of \< 4 mm Hg.
- •Ability to tolerate and self-administer vehicle eye drops to the satisfaction of study staff.
- •Tolerance of a commercially available benzalkonium chloride-preserved, artificial tear solution in one eye.
- •Normal slit lamp exam and dilated fundoscopic exam within 2 weeks of dosing.
- •Normal clinical laboratory profiles, defined as complete blood count, serum chemistry, and urinalysis values within the normal range.
- •Willing to abstain from the concomitant use of ocular or systemic medication (excluding acetaminophen and multivitamins) from 2 weeks prior to start of study dosing until study completion.
- •Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.
排除标准
- •Subjects who meet any of the following criteria are excluded from the study:
- •History of ocular surgery, trauma, or chronic ocular disease.
- •Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
- •Any ocular abnormalities or ocular symptoms (defined as a non-zero score on assessment scales).
- •Use of ocular agents (including eye drops) within the past 2 months or anticipated use of ocular agents during the study period.
- •Systemic corticosteroid use within the past 6 months.
- •History or evidence of ocular infection, inflammation, blepharitis, or conjunctivitis with 2 months; history of herpes simplex keratitis.
- •Presence of a nonhealing wound, ulcer, fracture, or any medical condition associated with bleeding.
- •Use of antimitotic or antimetabolite therapy within 2 months of enrollment.
- •Loss, donation, or removal of 400 mL or more of blood within the past 2 months.
结局指标
主要结局
Part A: Safety & tolerability of vehicle & 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 1 day, assessed up to 5 (+/- 1) days following dosing.
Part B: Safety & tolerability of 2 concentrations of TG100801 (ophthalmic examinations, ocular comfort ratings, ocular/systemic adverse events, lab tests) when administered twice a day for 14 days, assessed up to 7-14 days following dosing.
次要结局
- Systemic pharmacokinetics (Part B only)