NCT01015014已完成1 期
First-in-human, Two-stage, Randomized, Placebo-controlled, Double-blind, Dose Escalation Study To Determine The Safety, Tolerability, And Pharmacokinetic Profile Of An3365 In Single And Multiple Doses In Young Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, injection site tolerability, spontaneous/elicited adverse event reporting, and vital signs (blood pressure, heart rate, respiratory rate)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.
详细描述
Single-center, randomized, placebo-controlled, double-blind study to determine the safety, tolerability and pharmacokinetic profile of compound in single and multiple doses in young healthy males.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Young healthy males, 18-45 years (inclusive) of age
- •Healthy as judged by a responsible physician with no clinically significant abnormality
- •Surgically sterile OR agrees to abstain from sexual intercourse with a female partner OR agrees to use a condom and spermicide during sexual intercourse with a female partner who uses another form of contraception
- •Body weight above 50 kg (Body Mass Index between 19 and 30 kg/m2)
- •Non-smokers
- •Willing and able to comply with study instructions and commit to all follow-up visits
- •Ability to understand, agree to and sign the study Informed Consent Form (ICF)
排除标准
- •History of serious adverse reactions or hypersensitivity to any drug; or who have a known allergy to any of the test product(s) or any components in the test product(s); or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
- •Any clinically significant central nervous system, cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions
- •Abnormal physical findings of clinical significance at the screening examination or baseline
- •History of orthostatic hypotension
- •Clinically significant abnormal laboratory values
- •Presence or history of allergies requiring acute or chronic treatment
- •12 lead ECG abnormalities
- •Major surgical interventions within 6 months of the study
- •Has a positive pre-study Hepatitis B surface antigen; positive hepatitis C (HCV) antibody or detectable HCV ribonucleic acid (RNA); or positive HIV antibody result
- •Use of prescription or non-prescription drugs
- •Has a history of regular alcohol consumption
- •Loss of 500 mL blood or more during the 3 month period before the study
- •People that follow vegetarian or vegan diet
- •Symptoms of a significant somatic or mental illness in the four week period preceding drug administration
- •History of drug abuse or dependence within 12 months of the study
- •The subject has a positive pre-study alcohol or urine drug screen
- •Concurrent participation in another drug or device research study or within 60 days of post participation in another drug or device study
- •Considered by the Investigator to be unsuitable candidate for this study
研究组 & 干预措施
Saline
Placebo Comparator
干预措施: Placebo (Drug)
AN3365
Active Comparator
干预措施: AN3365 (Drug)
结局指标
主要结局
Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, injection site tolerability, spontaneous/elicited adverse event reporting, and vital signs (blood pressure, heart rate, respiratory rate)
时间窗: Multiple time points up to 14 days
次要结局
- Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality(Multiple time points up to 14 days)
研究者
研究点 (1)
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