NCT06625541已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of AJ302-IM in Healthy Volunteers Via Intramuscular Injection
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
- 57
- 试验地点
- 1
- 主要终点
- Incidence and proportion of volunteers with AEs including TEAEs and SAEs
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM following intramuscular administration of single ascending doses 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
- •Male or female, non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 55years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- •Normal renal function at screening.
- •Healthy as defined by:
- •The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
- •The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.
- •Able to understand the study procedures and provide signed informed consent to participate in the study
排除标准
- •Any clinically significant abnormal finding at physical examination
- •Any lifetime suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) in the 2 years before screening based on the C-SSRS
- •Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, at screening
- •Positive pregnancy test or lactating female volunteers
- •Positive urine drug screen, urine cotinine test, or alcohol breath test at screening and on Day -1
- •History of significant allergic reactions to any drug
- •Known allergy or hypersensitivity to histone deacetylase 6 (HDAC6) inhibitors or its derivatives and/or any study product excipients
- •Clinically significant ECG abnormalities or vital signs abnormalities at screening
- •History of drug abuse or recreational use of soft drugs or hard drugs
- •History of alcohol abuse
- •History of smoking or uses other nicotine-containing products
- •Undergone major surgery ≤ 2 months before study drug administration
- •History of clinically significant opportunistic infection or serious local infection or significant medical/surgical procedure or trauma, or any current infection.
- •Use of medications for the timeframes specified in the protocol
- •Received any investigational drug or any investigational device or any biological product within the timeframes specified in the protocol
- •Tattoos, sunburn, scarring or anything that may interfere with evaluation of the injection site
研究组 & 干预措施
AJ302-IM
Experimental
干预措施: AJ302-IM (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and proportion of volunteers with AEs including TEAEs and SAEs
时间窗: Baseline up to Day 57
次要结局
- Plasma PK of AJ302-IM(Pre-dose to Day 57)
- Urine PK of AJ302-IM(Pre-dose to Day 8)
研究者
研究点 (1)
Loading locations...
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