A First-in-Human Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of MAX-40070 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 78
- 主要终点
- Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments
研究概览
简要总结
This is a First-in-Human phase I study to evaluate the safety, tolerability and pharmacokinetic characteristics of MAX-40070 in Healthy SubjectThe study will be comprised of 2 parts; Part A and Part B. Part A will be conducted at NZCR, and Part B will be conducted at both NZCR and another site(s) in China (if required). Part A will include approximately 48 participants, and Part B will include approximately 30 participants.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weigh at least 50kg (females) or 55kg (males) and have a BMI between 20.0 kg/m2 - 30.0 kg/m
- •Subjects having no ulceration, damage, sunburn, redness, rash, acne, folliculitis, pigmentation, uneven skin tone, excessive freckles on the skin of the target application area and fever.
排除标准
- •An abnormality related to the comprehensive physical examination, laboratory test, 12-lead ECG, and other diagnostic tests and which is determined by the investigator as clinically significant (CS).
- •A history of CS diseases of heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system.
- •Intolerance to venipuncture for blood collection and/or having blood or needle phobia.
研究组 & 干预措施
MAX-40070
MAX-40070 is a liniment with two dose specification: 0.5%, 2% (Weight/Volume). In SAD phase, MAX-40070 will be applied once in each cohort, and there will be 6 cohorts. For the first 2 cohorts, 0.5% MAX-40070 will be used. For the rest 4 cohorts, 2% MAX-40070 will be used. In MAD phase, MAX-40070 2% will be applied once daily for consecutive 14 days in each cohort.
干预措施: MAX-40070 (Drug)
Placebo
Placebo is a liniment with two dose specification: 0.5%, 2% (Weight/Volume) to match with active drug in 2:1 manner ( 6 active: 2 placebo in each cohort).
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments
时间窗: 36 Days
skin irritation assessment will be performed during the treatment period. The dermal response score will be based on a visual irritation scale (0-7) that rates the degree of erythema, edema and other signs of cutaneous irritation. abnormal vital sign (including blood pressure, pulse rate, respiratory rate and oral temperatures), 12-lead ECG, hematology (hemoglobin, hematocrit, platelet count, RBC count, WBC count, with differential), blood chemistry (BUN, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, GGT, LDH, glucose, albumin, total protein, bicarbonate, phosphate, sodium, potassium, chloride, calcium, total cholesterol, uric acid) and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, nitrites, leukocytes, urobilinogen, microscopic urine analysis on abnormal findings) during the treatment period will be recorded and reported.
次要结局
- Time at which Cmax was first observed (Tmax)(1 Day)
- Maximum observed concentration (Cmax)(1 Day)
- Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)(1 Day)
- Area under the concentration curve for on dosing interval at steady state (AUC0-t)(36 Days)