A randomized, placebo-controlled study to evaluate the effects of intravenous sevuparin on dermal and systemic lipopolysaccharide responses and the interaction between subcuteneous enoxaparin and sevuparin on coagulation responses in healthy volunteers

Modus Therapeutics (Sweden)0 个研究点目标入组 83 人开始时间: 2023年10月2日最近更新: 2023年10月16日

适应症

试验速览

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•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, and a minimum body weight of 50 kg and a maximal body weight of 112 kg;
•3. No history of trauma with likely damage to the spleen or surgery to spleen;
•4. Free from any clinically significant febrile illness 30 days preceding study Day 1.

•1. History of sepsis, 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 unfractioned heparin;
•6. Subjects who have received prophylactic/therapeutic LMWH or unfractioned 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).

发起方

Modus Therapeutics (Sweden)