NCT04060173已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Phase 1b Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Administered Orally for 10 Days in Subjects With Hyperuricemia
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
- 27
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of ABP-671 administered orally in subjects with hyperuricemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be medically documented as healthy and acceptable at screening.
- •Subjects must have serum uric acid level at screening ≥ 7.0 mg/dL for men, ≥ 6.0 mg/dL for women.
- •Subjects must have a Body Mass Index (BMI) between 18.0 and 34.0 kg/m2 (inclusive).
- •Subjects must have a body weight of 50 kg or higher.
- •The subject agrees to abstain from alcohol consumption for 48 hours prior to dosing, for the duration of the in-house study period, and for 48 hours prior to each in-clinic follow up visit.
- •The subject is a nonsmoker.
- •Women must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal for ≥ 12 months.
- •Men must be surgically sterile, abstinent or if engaged in sexual relations with a female partner of child-bearing potential, the participant must be using a condom with spermicide from Screening and for a period of 30 days after the last dose of Study Drug. The Investigator will assess the adequacy of methods of contraception on a case-by-case basis.
- •Subjects must have a complete blood count (CBC) and platelet count within the normal range or considered not clinically significant by the principal investigator.
- •Other than elevated serum uric acid, subjects must have normal blood chemistry or results considered not clinically significant by the investigator.
- •Subjects must have a normal urinalysis or results considered not clinically significant by the investigator including a normal protein/creatinine ratio per local lab reference ranges (≤ 200 mg/g) and a urine creatinine result that does not exceed 300 mg/dL. Any out of range values may be repeated per Investigator discretion.
- •Subjects must have a normal ECG or results considered not clinically significant by the principal investigator.
- •Subjects must be able to comply with the study and follow-up procedures.
- •Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
排除标准
- •Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- •Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen, and/or Hepatitis C virus.
- •Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 3 weeks before Day 1 of study medication dosing.
- •Subjects who are positive for urine drug and alcohol screening tests.
- •Subjects who have undergone major surgery within 3 months prior to Day
- •Women who are pregnant or breastfeeding.
- •Subjects who received any investigational test article within 5 half-lives or 30 days, whichever is longer, prior to Day 1 study medication dosing.
- •Recent blood donation for more than 500 mL within 2 months of screening.
- •Abnormal ECG including QTc > 470 (F) and > 450 (M).
- •Subjects who consumed Seville oranges- or grapefruit-containing foods or beverages within 7 days before Day 1 and during the entire study duration.
- •Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
- •Prior exposure to ABP-671.
研究组 & 干预措施
Treatment with ABP-671
Experimental
Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days.
干预措施: ABP-671 (Drug)
Treatment with placebo
Placebo Comparator
Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: 38 days
Measured by the number of patients with AEs
次要结局
- Area under time-concentration curve (AUC)(2 weeks)
- Maximum observed plasma concentration of ABP-671 (Cmax)(2 weeks)
- Volume of distribution (Vd)(2 weeks)
- Half life of ABP-671 (t1/2)(2 weeks)
- The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid(24 days)
- The effect of ABP-671 versus placebo on change in urine uric acid excretion(24 days)
- Time of maximum observed plasma concentration of ABP-671 (Tmax)(2 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
A Clinical Study of SCTC21C in Participants With Plasma Cell-driven Autoimmune DiseasesIgA NephropathyNCT06774664Sinocelltech Ltd.99
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy AdultsHealthy Adult SubjectsNCT04629131Zhuhai Trinomab Pharmaceutical Co., Ltd.32
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Chinese Healthy AdultsHealthy VolunteersNCT05842798Zhuhai Trinomab Pharmaceutical Co., Ltd.28
招募中
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ID110521156 in Healthy Adult SubjectsHealthy Adult SubjectsNCT06635226IlDong Pharmaceutical Co Ltd36
已完成
2 期
A Safety PK/PD Study of SLV337 in Patients With Type 2 DiabetesType 2 DiabetesNCT00924534Abbott Products61