A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Active Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 28
- 主要终点
- Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC)
研究概览
简要总结
This is a Phase 1b, randomized, double-blind, multicenter dose-ranging study to evaluate the safety, tolerability, and PK of NX-13. Approximately 40 subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) (12 evaluable subjects at each of the 3 dose levels) or placebo (4 subjects), once daily for 28 consecutive days.
详细描述
Following screening period (up to 28 days in length), a total of 40 subjects are planned to be enrolled into this study from multiple sites in the United States, Australia, New Zealand, and Moldova. Eligible subjects will be randomized in a 3:3:3:1 ratio to receive 1 of 3 NX-13 treatment regimens (NX-13 250 mg IR, 500 mg IR, 500 mg MR) or placebo via a computer-generated interactive web response system (IWRS). Each of the NX-13 treatment groups will comprise 12 subjects and 4 subjects will be randomized to receive placebo. The study will include a maximum of 25% of subjects who have had prior exposure to biologic therapy for UC.
Dosing will extend over a 28-day period at each dose level. Subjects will receive the first dose of study drug in clinic on Day 1 (Visit 2) and Day 28 (Visit 4/EOT) but will self-administer IP at home once daily for the remaining dosing days. The study duration will be approximately 63 days: Screening Period (28 days) + Treatment Period (28 days) + Safety Follow-up (7 days after last dose). There will be a follow-up visit on Day 35 (Visit 5).
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
- Triple (Participant, 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
- •male and female subjects aged 18 to 75 years (inclusive) with a diagnosis of UC ≥ 90 days before screening;
- •active UC defined as a total Mayo Score of 4 to 10 (inclusive), at baseline, with a Mayo endoscopic subscore (MES) ≥ 2 confirmed by a central reader;
- •baseline fecal calprotectin ≥ 250 μg/g;
- •biologic-naïve or having stopped biologic therapy ≥ 8 weeks before the start of the study;
- •5-aminosalicylates must be stable for ≥ 1 month prior to randomization.
排除标准
- •Crohn's disease (CD), indeterminate colitis, or presence or history of fistula with CD;
- •a history of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma;
- •history of or at imminent risk of colectomy;
- •history of or current colonic dysplasia ;
- •recent history (within 2 years prior to randomization) or current adenomatous colonic polyps;
- •treatment with an immunosuppressant within 3 months of randomization;
- •bacterial or parasitic pathogenic enteric infection;
- •live virus vaccination within 1 month prior to screening.
研究组 & 干预措施
NX-13 250mg IR
Oral
干预措施: NX-13 250mg IR (Drug)
NX-13 500mg IR
Oral
干预措施: NX-13 500mg IR (Drug)
NX-13 500mg MR
Oral
干预措施: NX-13 500mg MR (Drug)
Placebo
Oral
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13 in subjects with active ulcerative colitis (UC)
时间窗: 63 days
Incidence of Treatment-Emergent Adverse Events after multiple oral dose administration of NX-13
次要结局
- PK profile of NX-13 after multiple oral dose administration in subjects with active UC(63 days)
- PK Parameters - Time to maximum concentration (tmax);(63 days)
- PK Parameters- Maximum concentration (Cmax)(63 days)
- PK Parameters- Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-tlast);(63 days)
- PK Parameters-Terminal half-life (t1/2)(63 days)
- PK Parameters- clearance (CL);(63 days)
- PK Parameters- Vz, apparent volume of distribution during terminal phase.(63 days)