A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Events following oral dosing
研究概览
简要总结
SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or females, of any ethnic origin.
- •Established diagnosis of UC by standard criteria for >3 months.
- •Disease evaluable by sigmoidoscopy.
- •Mildly to severely active UC as determined by central reader in combination with other assessments of disease
排除标准
- •Any diagnosis of IBD except for UC.
- •History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon.
- •Concurrent use of any biologic drug.
- •Prior primary efficacy failure or secondary loss of response to more than one biologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptor modulators) indicated for the treatment of UC. This does not include prior discontinuation due to drug intolerance.
研究组 & 干预措施
Part 3 SOR102 QD
SOR102 once a day for 6 weeks SOR102 oral capsules
干预措施: SOR102 (Drug)
Part 3 SOR102 BID
SOR102 twice a day for 6 weeks SOR102 oral capsules
干预措施: SOR102 (Drug)
Part 3 Placebo
Placebo for twice a day for 6 weeks Placebo oral capsules
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events following oral dosing
时间窗: Up to 6 weeks in Part 3 or at the time of study discontinuation
After multiple oral doses administered BID or QD, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group
次要结局
- Incidence of positive neutralizing ADA(Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation)
- SOR102 concentrations following oral dosing(Up to 6 weeks in Part 3 or at the time of study discontinuation)
- Incidence of positive ADAs to SOR102(Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation)