A Phase I, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of ASC50 Tablets in Healthy Adult Participants and Adult Participants With Mild to Moderate Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.
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
- 是
入选标准
- •Male and female participants between 18 to 65 years of age inclusive, at the time of screening.
- •Willing and able to give informed consent prior to any study specific procedures being performed.
- •Have venous access sufficient to allow for blood sampling
排除标准
- •Female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose.
- •History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator.
- •Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
- •Have any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
研究组 & 干预措施
SAD Cohort 2
Participants will receive a single ASC50 (Dose 2) administration or matching placebo
干预措施: ASC50 tablets or matching placebo (Drug)
SAD Cohort 1
Participants will receive a single ASC50 (Dose 1) administration or matching placebo
干预措施: ASC50 tablets or matching placebo (Drug)
SAD Cohort 3
Participants will receive a single ASC50 (Dose 3) administration or matching placebo
干预措施: ASC50 tablets or matching placebo (Drug)
SAD Cohort 4
Participants will receive a single ASC50 (Dose 4) administration or matching placebo
干预措施: ASC50 tablets or matching placebo (Drug)
SAD Cohort 5
Participants will receive a single ASC50 (Dose 5) administration or matching placebo
干预措施: ASC50 tablets or matching placebo (Drug)
SAD Cohort 6
Participants will receive a single ASC50 (Dose 6) administration or matching placebo
干预措施: ASC50 tablets or matching placebo (Drug)
MAD Cohort 1
Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD
干预措施: ASC50 tablets or matching placebo (Drug)
MAD Cohort 2
Participants will receive ASC50 (Dose 2) or matching placebo for 28 days, QD
干预措施: ASC50 tablets or matching placebo (Drug)
MAD Cohort 3
Participants will receive ASC50 (Dose 3) or matching placebo for 28 days, QD
干预措施: ASC50 tablets or matching placebo (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to Day 43
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
次要结局
- Beta Defensin-2(Up to Day 29)
- AUC(Up to Day 34)
- Cmax(Up to Day 34)
- T1/2(Up to Day 34)
- Tmax(Up to Day 34)
- IL-17A(Up to Day 29)
- IL-19(Up to Day 29)
- Psoriasis Area and Severity Index (PASI)(Up to Day 43)
- Target Lesion Severity Score (TLSS)(Up to Day 43)