NCT01287858已完成1 期
A Phase 1, Randomized, Double Blind, Placebo Controlled, Sequential, Ascending Single-Dose and Multiple-Dose First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC430 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.
研究概览
简要总结
AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2 hours after dosing) with approximately 240 mL of water either once daily or twice daily. It is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.
详细描述
A dose-finding study of AC430 in healthy volunteers.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy normal males and females, age 18 to 45, inclusive, at the time of consent
- •Able to communicate effectively in the English language
- •Able to provide valid, written informed consent
- •Able to swallow up to 20 capsules of study drug
- •BMI (body mass index) ranging between 18 and 30 kg/m2, inclusive
- •Minimum weight of 50 kg
- •Serum Creatinine ≤ ULN (upper limit of normal) and estimated creatinine clearance at screening of ≥ 80 mL/min per the Cockcroft-Gault equation
- •Total serum bilirubin ≤ ULN (may be repeated to confirm eligibility)
- •Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ ULN (may be repeated to confirm eligibility)
- •Male subjects must either be sterile or agree to use from Check-in until 90 days following the last dose of AC430, an acceptable form of birth control.
- •Female participants must be either of non-child-bearing potential or agree to use an acceptable form of birth control.
排除标准
- •History of clinically significant drug allergy
- •Participation in another clinical trial with receipt of an Investigational Product within 90 days before dose administration (or 5 half-lives, whichever is longer)
- •Major surgery within 90 days before study enrollment
- •Use of prescription, over the counter, or herbal medications or supplements, including oral contraceptives within 14 days of check-in
- •A history of drug abuse or a history of alcohol abuse within 1 year prior to Screening
- •Current or recent (within 30 days before enrollment) use of tobacco or nicotine products
- •Consumption of alcohol containing beverages > an average of 14 drinks per week or unwillingness to refrain from ethanol consumption while confined to the study unit
- •Inadequate venous access that would interfere with obtaining blood samples
- •Recipients of blood transfusion or transfusion of blood or plasma products, within 90 days before study drug administration
- •Donation of blood ≥ 500 mL within 2 months before study drug administration
- •History or positive laboratory evidence of Human immunodeficiency virus (HIV), Hepatitis B antigen and antibody, or Hepatitis C, or history of Tuberculosis (TB) infection, or a positive result for Quantiferon Gold test
- •Prolonged average of the corrected QTc by Fridericia's correction factor (QTcF) interval on screening electrocardiogram (ECG) triplicate (≥ 450 ms for males and ≥ 470 ms for females)
- •Abnormal laboratory values that are considered clinically significant by the Investigator
- •History of cancer
- •History of eating disorders within the past 3 months
- •History of a seizure disorder or clinically significant head injury
- •Positive urine drug screen for drugs of abuse including alcohol
- •Active infection within 90 days of check-in
- •Medical condition, serious intercurrent illness, cardiovascular, pulmonary, neurologic, psychiatric, renal, hepatic or gastrointestinal disease, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize subject safety or interfere with the objectives of the study
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: AC430 (Drug)
AC430
Active Comparator
AC430
干预措施: AC430 (Drug)
结局指标
主要结局
Assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.
时间窗: 6 months
* Number of participants with adverse events as measurement of safety and tolerability of AC430. \[Time frame: 1-28 days\] * Maximum concentration (Cmax) for AC430 in plasma (measured in ng/mL) \[Time frame: 1-28 days\] * Tmax = Time of maximum concentration of AC430 in plasma (hr) \[Time frame: 1-28 days\] * AUC = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) \[Time frame: 1-28 days\] * Urine: amount of AC430 excreted in urine (Ae0-48), renal clearance (CLr) and fraction of drug excreted in urine (Fe). \[Time frame: 1-28 days\]
次要结局
- Determine the pharmacodynamic effects of single and multiple oral doses of AC430.(Measured at specific timepoints prior to and following dosing regimen.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-3 and BR1015-2 Under Fasting ConditionsEssential HypertensionNCT06744426Boryung Pharmaceutical Co., Ltd60
已完成
1 期
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-1 and BR1015-2 Under Fasting ConditionsEssential HypertensionNCT06744127Boryung Pharmaceutical Co., Ltd58
已完成
1 期
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fasting Conditions in Healthy VolunteersHypertensionNCT06008028Boryung Pharmaceutical Co., Ltd57
已完成
1 期
Phase 1 Study to Evaluate Safety and Pharmacokinetics of FZJ-003 in Healthy VolunteersHealthy VolunteersNCT04715529Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.62
已完成
1 期
The Tolerance, Pharmacokinetics of Jaktinib in Healthy VolunteersHealthy VolunteersNCT03314402Suzhou Zelgen Biopharmaceuticals Co.,Ltd126