A Phase 1, Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered ABF- 101
概览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Number of Participants with treatment-emergent adverse event
概览
简要总结
This is a Phase 1 study to evaluate the safety, tolerability, PK, and PD of ABF-101 in healthy participants and participants with age-related macular degeneration (AMD).
详细描述
Part A will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants.
Part B will be a randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy participants.
Part C will be an open-label study in participants with AMD. For Part A and B, serial blood samples will be collected to assess the PK of ABF-101. Ocular examinations will be conducted to evaluate changes in ocular characteristics and function.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part A and B
- •Healthy participants, aged between 18 and 50 years
- •Provides written, signed, informed consent prior to selection
- •BMI of ≥ 18.0 and \< 32.0 kg/m2, and body weight between 50 kg and 115 kg, inclusive.
- •Vital signs: normal pulse rate and blood pressure.
- •Must be willing to abstain from caffeine and alcohol
- •Must be willing to avoid strenuous activity
- •Confirmed diagnosis of AMD
- •Male or female ≥50 years of age
- •Adequate visual acuity in the non-study eye
排除标准
- •Part A and B
- •Any history or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease
- •Any significant abnormalities detected during ocular examination,
- •Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
- •Any drug intake (except paracetamol or contraceptives)
- •History or presence alcohol abuse
- •History or presence of drug abuse
- •Positive HBsAg or anti-HCV antibody, or positive results for HIV
- •Blood donation, significant blood loss, or has received a transfusion of any blood or blood products
- •Female participants who are breastfeeding.
研究组 & 干预措施
Part A (ABF-101 or Placebo)
- Part A (Phase 1a) will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants.
- Capsule, single oral dose
干预措施: ABF-101 (Drug)
Part A (ABF-101 or Placebo)
- Part A (Phase 1a) will be a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy participants.
- Capsule, single oral dose
干预措施: Placebo (Drug)
Part B (ABF-101 or Placebo)
- Part B (Phase 1b) will be a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in healthy participants.
- Capsule, once daily by mouth
干预措施: ABF-101 (Drug)
Part B (ABF-101 or Placebo)
- Part B (Phase 1b) will be a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study in healthy participants.
- Capsule, once daily by mouth
干预措施: Placebo (Drug)
Part C (ABF-101)
- Part C will be an open-label study in participants with AMD
- Capsule, once daily by mouth
干预措施: ABF-101 (Drug)
结局指标
主要结局
Number of Participants with treatment-emergent adverse event
时间窗: From enrollment up to 12 weeks
To investigate the safety and tolerability of single ascending dose of ABF-101orally administered in healthy participants (Part A and B) and in AMD (Part C)
次要结局
- Terminal elimination half-life of ABF-101(From enrollment up to 12 weeks)
- Maximum Observed Plasma Concentration (Cmax) of ABF-101(From enrollment up to 12 weeks)
- The plasma area under the curve (AUC) of ABF-101(From enrollment up to 12 weeks)
- Time to maximal concentration (Tmax) of ABF-101(From enrollment up to 12 weeks)