NL-OMON52250已完成不适用
A randomized, placebo-controlled study to evaluate the effects of intravenous sevuparin on dermal and systemic LPS responses and the interaction between subcutaneous enoxaparin and sevuparin on coagulation responses in healthy volunteers. - Inhibition of LPS responses by sevuparin
Modus therapeutics Inc.0 个研究点目标入组 64 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
- 64
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. Healthy male and female volunteers aged 18 to 55 years, inclusive. Health
- •status is defined by absence of evidence of any active or chronic disease
- •following a detailed medical and surgical history, a complete physical
- •examination including vital signs, 12-lead ECG, haematology, blood chemistry,
- •and urinalysis;
- •2. BMI in the range of 18 to 30 kg/m2, a minimum body weight of 50 kg and a
- •maximum body weight of 112 kg;
- •3. Be able to abstain from smoking from 24 hours prior to dosing until study
- •discharge visit;
- •4. No history of alcohol or drug abuse;
- •5. No history of trauma with likely damage to the spleen or surgery to spleen;
- •6. Free from any clinically significant febrile illness 30 days preceding study
- •7. Non-atopic constitution, including non-asthmatic;
- •8. Fitzpatrick skin type I-III (applicable to Part 1 and 2 only);
- •9. No use of any prescription drugs, including aspirin or other non-steroid
- •anti-inflammatory drugs;
- •10. Able to give written informed consent and willing to comply with all
- •study-related procedures;
- •11. Female subjects of childbearing potential and male subjects who have sexual
- •intercourse with a woman of childbearing potential must be willing to practice
- •effective contraception during the study and be willing and able to continue
- •contraception for at least 90 days after their last dose of study treatment.
- •Women of childbearing potential are defined as all women physiologically
- •capable of becoming pregnant, unless they meet one of the following conditions:
- •Postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks
- •after surgical bilateral oophorectomy with or without hysterectomy;
- •Posthysterectomy.
- •For the purposes of the study, effective contraception is defined as follows:
- •Females: Using 1 or more of the following acceptable methods of
- •contraception: surgical sterilization (e.g., bilateral tubal ligation),
- •intrauterine contraception/device, hormonal contraception, or any 2 barrier
- •methods (a combination of male or female condom with diaphragm, sponge or
- •cervical cap).
- •Males: Effective male contraception includes a vasectomy with negative semen
- •analysis at follow up, or the use of condoms.
- •Abstinence can be considered an acceptable method of contraception at the
- •discretion of the investigator. Periodic abstinence (e.g., calendar, ovulation,
- •symptothermal, post ovulation methods) and withdrawal are not considered
- •acceptable methods of contraception.
排除标准
- •1. History of sepsis or history of clinically significant cardiovascular
- •disease, syncope or malignancy;
- •2.Haemorrhagic diathesis (easy bruising, epistaxis, gastro-intestinal bleeding);
- •3.First degree family history of premature cardiovascular disease event (if
- •diagnosed before 50 years of age);
- •4.Previous participation in a systemic (i.v./inhaled) LPS challenge trial or
- •prior exposure to systemic endotoxin within a year before the first study day
- •(applicable to Part 1 and 2 only) or previous exposure to sevuparin in study
- •Part 1 or 2 (applicable to Part 3 only);
- •5.Subjects who have received any of the following excluded medications within
- •prescribed 14 days of the first dose administration: aspirin, anti-platelet
- •therapy, anticoagulant therapy and prophylactic and therapeutic LMWH or
- •un-fractioned heparin
- •6. Subjects who have received prophylactic/therapeutic LMWH or un-fractioned
- •heparin within the last year;
- •7. Subjects who have any current and / or recurrent pathologically, clinically
- •significant skin condition at the lower forearms (i.e. atopic dermatitis);
- •including tattoos (applicable to Part 1 and 2 only).
- •8. Subject is female and is pregnant (based upon serum pregnancy test at
- •screening and urine pregnancy test pre-dose to the first sevuparin/placebo
- •administration), breast-feeding, or planning to become pregnant during the
- •study or within 90 days after last dose of study treatment.
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