NCT01982747已完成1 期
A Phase I, Placebo-Controlled, Double-Blind, 2-Period Crossover Study to Assess Cardiac and General Safety and Pharmacokinetics of a Single Subcutaneous Dose of 60 mg MGN1703 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
- 发起方
- Mologen AG
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- cardiac safety of MGN1703 as compared to placebo
研究概览
简要总结
MGN1703 is being developed for use in treating cancerous tumors effecting the colon, skin, kidneys and lungs. The dosage form of MGN1703 under investigation is an injection.
The goal of this study is to evaluate the effects of MGN1703 on the electrical activity of the heart in healthy subjects and to look at general safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •The subject signs an IRB/IEC-approved informed consent prior to any study-related procedures.
- •Subject is male or female with no less than 6 subjects per sex in the study.
- •Subject is 18 to 65 years of age.
- •Subject's BMI is ≤32 kg/m
- •Female subjects of childbearing potential must not be pregnant or lactating with a negative serum HCG pregnancy test result at Screening and a negative urine HCG pregnancy test result on Days -1 and 14 prior to receiving study medication.
- •Female subjects of childbearing potential and male subjects must use an adequate method of contraception from Screening until completion of the study. Acceptable methods of contraception are barrier methods (male condom, female condom, diaphragm, cervical cap, spermicide or IUD), surgical sterility (documented doctor's report of vasectomy, hysterectomy and/or bilateral oophorectomy) and/or postmenopausal status (defined as at least 1 year without menses as demonstrated by medical history or subject report).
- •Subject is in good health as determined by vital signs, medical history, physical exam, and safety laboratory analyses at Screening and during the study.
排除标准
- •Subject has used an investigational product within 30 days prior to screening or during the study.
- •Subject has used prescription or non-prescription drugs (including vitamins, minerals, and herbal/plant-derived preparations) within 2 weeks of Screening (excluding oral contraceptives, hormonal IUD, hormone replacement therapy and acetaminophen) unless deemed acceptable by the Investigator in consultation with the Sponsor.
- •Subject has a positive drug and/or alcohol test at Screening, Day -1 or Day
- •The subject has a history of drug or alcohol abuse within 2 years before Screening.
- •The subject is unable to abstain from ingesting alcohol, caffeine, grapefruit or Grapefruit juice for 72 hour prior to dosing.
- •The subject has a clinically significant history of cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases or malignancy.
- •Subject has a history of cardiac disease or any risk factors for TdP including (but not limited to) unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, structural heart disease and family history of Long QT syndrome.
- •Subject has evidence of any of the following cardiac conduction abnormalities at Screening, Day -1 or Day 1 prior to receiving any study medication:
- •QTcF interval >430 msec for males and >450 msec for females
- •PR interval >240 msec or <110 msec
- •Evidence of second- or third-degree AVB
- •Electrocardiographic evidence of complete LBBB, complete RBBB or incomplete LBBB
- •Intraventricular conduction delay with QRS duration >120 msec
- •Heart rate <40 bpm or >90 bpm
- •Pathological Q waves (defined as >40 msec or depth >0.4-0.5 mV)
- •Evidence of ventricular pre-excitation
- •The safety laboratory analyses at Screening are outside the normal limits and considered by the Investigator as clinically significant.
- •Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study, a history of noncompliance to medical regimens, or subjects who are considered to be potentially unreliable.
- •The subject has a positive test result for HIV antibody.
- •The subject has a positive test result for the hepatitis C antibody or the HBsAg.
研究组 & 干预措施
MGN - Placebo
Other
Subjects of the MGN-Placebo arm will receive 60mg MGN1703 as 2 s.c. injections of 2 ml each during period 1 and physiological saline solution as Placebo as 2 s.c. injections of 2 ml each during period 2
干预措施: MGN-Placebo (Drug)
Placebo-MGN
Other
Subjects of the Placebo-MGN arm will receive physiological saline solution as Placebo as 2 s.c. injections of 2 ml each during period 1 and 60mg MGN1703 as 2 s.c. injections of 2 ml each during period 2
干预措施: Placebo-MGN (Drug)
结局指标
主要结局
cardiac safety of MGN1703 as compared to placebo
时间窗: within the first 5 days after dosing
assessed by 12 lead ECG
次要结局
- general safety of MGN1703 as compared to placebo(within 5 days after dosing)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon CancerNeoplasms, ColonNCT06567782GlaxoSmithKline120
已完成
2 期
Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)Neuroendocrine TumorsMetastatic Neuroendocrine TumorsNCT00610129Memorial Sloan Kettering Cancer Center25
终止
1 期
A Safety and Tolerability Study of NC762 in Subjects With Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid TumorsBreast CancerOvarian CancerNon-small Cell Lung CancerNCT04875806NextCure, Inc.40
招募中
1 期
Safety and Tolerability Study of GIM-531 in Advanced Solid TumorsMelanoma Stage IVSolid TumorNCT06425926Georgiamune Inc117
终止
1 期
Study of AK119 Combined With AK104 in Patients With Advanced Solid TumorsSolid Tumor, AdultNCT05559541Akeso33