NCT06048887已完成1 期
A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers
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
- Percentage of subjects with treatment-emergent adverse events
研究概览
简要总结
A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study
- •Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential
- •ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening
排除标准
- •Use of topical, nasal, inhaled, or oral corticosteroids.
- •Use of any investigational drug within the past 60 days.
- •Have a medically significant illness within 30 days prior to screening.
- •Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.
- •Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
- •Unstable psychological disorder ≤1 year prior to Screening.
研究组 & 干预措施
Single Ascending Dose (Part 1)
Experimental
干预措施: CRN04894 Oral Solution (Drug)
Single Ascending Dose (Part 1)
Experimental
干预措施: Placebo Oral Solution (Drug)
Multiple Ascending Dose (Part 2)
Experimental
干预措施: CRN04894 Oral Solution (Drug)
Multiple Ascending Dose (Part 2)
Experimental
干预措施: Placebo Oral Solution (Drug)
结局指标
主要结局
Percentage of subjects with treatment-emergent adverse events
时间窗: Part 1 - up to Day 8; Part 2 - up to Day 20
Proportion of participants with a clinically significant safety laboratory observation
时间窗: Part 1 - up to Day 8; Part 2 - up to Day 20
次要结局
- Pharmacokinetics (Cmax)(Part 1 - up to Day 8; Part 2 - up to Day 20)
- Pharmacokinetics (Tmax)(Part 1 - up to Day 8; Part 2 - up to Day 20)
- Pharmacokinetics (AUC)(Part 1 - up to Day 8; Part 2 - up to Day 20)
- Pharmacokinetics (T1/2)(Part 1 - up to Day 8; Part 2 - up to Day 20)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
1 期
The Safety, Tolerability, PK, and PD of DWP213388 After SAD and MAD Administration in Healthy Adult SubjectsHealthyNCT05607589Daewoong Pharmaceutical Co. LTD.72
Unknown
1 期
A Trial to Evaluate Safety, Tolerability, PK and Antiviral Activity of MB-110 in Hepatitis C Virus Infected PatientsChronic Hepatitis CNCT02617615Microbio Co Ltd40
已完成
1 期
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy SubjectsHealthy VolunteersNCT04497662Kiniksa Pharmaceuticals, Ltd.52
已完成
1 期
A First-in-Human SAD/MAD Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC1018 in Healthy Adult SubjectsHealthyNCT06224400EnnovaBio Australia Pharmaceuticals Pty Ltd72
已完成
1 期
SCB-2019 as COVID-19 VaccineCOVID-19NCT04405908Clover Biopharmaceuticals AUS Pty Ltd166