NL-OMON45336已完成不适用
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics of Minocin® (minocycline) for Injection in Healthy Adult Subjects - MDCO-MIN-16-02 (CS0275)
Medicines Company0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. A signed informed consent form, the ability to understand the study conduct and tasks that are
- •required for study participation, and a willingness to cooperate with all tasks, tests, and
- •examinations as required by the protocol, whether in the research unit or after discharge, for the
- •duration of the study;
- •2. Male or female between 18 and 50 years of age inclusive;
- •3. Subject has a body mass index (BMI) *18 kg/m2 and * 30 kg/m2;
- •4. Subject is non-smoker or smokes up to 5 cigarettes per day (or equivalent).
- •5. Subject is in good health based on medical history and physical
- •examination findings and has no clinically meaningful safety laboratory abnormalities
- •(Haematology, blood chemistry, and urinalysis) or 12-lead ECG results, as assessed by the
- •Principal Investigator (PI);
- •6. Vital signs (BP, pulse, respiratory rate and temperature) measured at screening/baseline must
- •be within the following ranges: SBP *90 to *150 mm Hg, DBP *45 to *90 mm Hg; Heart Rate *
- •45 to *90 bpm (taken after resting in a supine position for at least 5 minutes);
- •7. Expectation that intravenous access will be sufficient to allow for ease of study drug infusion,
- •and for all protocol required blood sampling to take place;
- •8. Subject commits to remaining admitted in the research unit for the course of the study;
- •9. Female subject is surgically sterile, postmenopausal: period of amenorrhea
- •for at least 2 years, or if of childbearing potential, agrees to abstinence or to use at least 2
- •acceptable methods of birth control (e.g. prescription oral contraceptives, contraceptive
- •injections, contraceptive patch, intrauterine device, barrier methods, etc.) or male partner
- •sterilization alone, between the first dose (Day 1) and for 90 days after the completion of the
排除标准
- •1. Has any condition, including findings in the medical history or in pre-study assessments that
- •constitutes a risk or a contraindication for the participation in the study or completing the study;
- •2. Positive breath test for alcohol and/or positive urine test for drugs of abuse at Screening and
- •Day -1 Visits;
- •3. Has a history or presence of alcohol/drug abuse within 2 years. Alcohol abuse is defined as
- •regularly consuming >3 units/day (21 units per week for men), >2 units/day (14 units/week) for
- •women. A unit is defined as a can of 4% beer (330 mL), approximately 190 mL of 6-7% beer
- •(malt liquor), a glass of 40% spirits (30 mL), a glass of wine (100 mL);
- •4. Subject shows positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-
- •HCV), or human immunodeficiency virus (HIV) I/II antibodies and antigen tests;
- •5. Subject has active or ongoing candida infection;
- •6. Blood or plasma donation within past 2 months;
- •7. Females who are pregnant or nursing or who have a positive pregnancy test result at the
- •screening Visit or Day -1 prior to dosing;
- •8. Males who are unwilling to practice abstinence or use an acceptable method of birth control
- •during the entire study period and for 90 days after the completion of the study (i.e. condom with
- •spermicide, where locally available) ;
- •9. Presence of known raised intracranial pressure;
- •10. Use of retinoids (e.g., Isotretinoin);
- •11. History of significant hypersensitivity or allergic reaction to any of the tetracycline class of
- •antibiotics or the components of those antibiotics;
- •12. Receipt of any investigational medication or investigational device during the last 30 days prior
- •to randomization;
- •13. Treatment with any prescription, vitamins or OTC drugs, within 2 weeks or five half-lives,
- •whichever is longer, or herbal nutritional supplements within 2 weeks of screening, with the
- •exception of acetaminophen/paracetamol for minor headache. Subjects will not be allowed to
- •receive medications for the duration of the study (except the abovementioned
- •acetaminophen/paracetamol). Birth control or other hormone replacement is also permitted as
- •long as it has been taken at a stable dose for at least three months before the Screening Visit
- •and remains stable for the duration of the study;
- •14. A QTcF >480 msec;
- •15. Calculated creatinine clearance less than 50 mL/min (Cockcroft-Gault method) at screening or
- •check-in (Day -1)
- •16. Unable or unwilling, in the judgment of the Investigator, to comply with the protocol;
- •17. An employee of the Investigator, the study center, the sponsor or The Medicines Company with
- •direct involvement in the proposed study or other studies under the direction of that Investigator
- •or study center, or a family member of the employee or the Investigator:
- •18. Prior enrollment in any minocycline study including prior cohorts in this trial;
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