NCT05275855已完成1 期
A First-in-human, Randomized, Participant and Investigator Blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
A first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of EDI048 administered orally in healthy volunteers.
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
- 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
- •Healthy male and female participants 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m
- •BMI = Body weight (kg) / [Height (m)]2
- •At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the participant has rested for at least three (3) minutes, and again in the standing position. Supine vital signs should be within the following ranges:
- •oral body temperature between 35.0-37.5 °C
- •systolic blood pressure, 90-139 mmHg
- •diastolic blood pressure, 50-89 mmHg
- •pulse rate, 40-90 bpm
排除标准
- •Participants who have received any IMP in a clinical research study within 90 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations.
- •History of multiple and recurring allergies or allergy or hypersensitivity to any of the study treatments, excipients or drugs of similar chemical classes. Hay fever is allowed unless it is active at time of screening or if there is a risk that it may become active during the study.
- •Pregnant or nursing (lactating) women, assessed at screening and baseline.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- •Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 7 days after stopping the investigational drug.
- •Additional protocol-defined inclusion / exclusion criteria may apply.
研究组 & 干预措施
Part A: EDI048 or Placebo
Experimental
Part A is a single ascending dose study
干预措施: EDI048 (Drug)
Part A: EDI048 or Placebo
Experimental
Part A is a single ascending dose study
干预措施: Placebo (Other)
Part B: EDI048 or Placebo
Experimental
Part B is a multiple ascending dose study
干预措施: EDI048 (Drug)
Part B: EDI048 or Placebo
Experimental
Part B is a multiple ascending dose study
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with Adverse Events (AEs)
时间窗: From the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 8.5 weeks for Part A and 9 weeks for Part B
Number of participants with AEs and Serious Adverse Events (AEs), including significant changes from baseline in vital signs, electrocardiograms and laboratory assessments qualifying and reported as AEs.
次要结局
- Parts A and B: T1/2(up to 13 days)
- Parts A and B: AUClast(up to 13 days)
- Part B: Accumulation (Racc)(up to 13 days)
- Parts A and B: Cmax(up to 13 days)
- Parts A and B: Tmax(up to 13 days)
- Parts A and B: AUCinf(up to 13 days)
- Part B: AUC0-12h(up to 13 days)
- Part A: Renal Clearance (CLr)(up to 13 days)
- Part A: Ae0-t(up to 3 day)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
AZD5985 Single Ascending Dose StudyHealthyNCT00967356AstraZeneca72
已完成
1 期
Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy VolunteersHealthy Adult SubjectsNCT02168595GlycoMimetics Incorporated28
已完成
1 期
First-in-human Study of Orally Administered KT-621 in Healthy Adult ParticipantsHealthy Participants StudyNCT06673667Kymera Therapeutics, Inc.118
进行中（未招募）
1 期
Phase 1 Study of OLX-07010 in Healthy Adult and Elderly ParticipantsAlzheimer DiseaseNCT05696483Oligomerix, Inc76
Unknown
1 期
Evaluation the Pharmacokinetics, Safety, Tolerability of TK001 in Patients With Neovascular Age-related Macular DegenerationNeovascular Age-related Macular DegenerationNCT02613559Jiangsu T-Mab Biopharma Co.,Ltd27