OX-A12 to Mobilize Stem Cells in Healthy Volunteers - A Single-center, Single Dose, Open Label, Dose Escalation Study of Intravenous NOX-A12 in up to 42 Healthy Subjects - NOX-A12 First-in-human (FIH) Study

OXXON Pharma AG0 个研究点目标入组 48 人开始时间: 2009年9月25日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Healthy male and female subjects willing to use appropriate contraception methods
•- Body mass index 19 - 29 kg/m2 (extremes included)
•- Body weight between 50 and 100 kg (extremes included)
•- Calculated creatinine clearance >80 mL/min
•- Normal lung function (FVC and FEV1 at least 80% of predicted values)

•- Abnormal spleen size
•- History of thrombosis
•- Intake of any prescribed systemic or topical medication within 14 days prior to dosing
•- History of relevant heart disorders or evidence of hyper- or hypotension (sitting blood pressure systolic >140 mmHg or <95 mmHg or diastolic >90 mmHg or <65 mmHg)
•- Evidence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, hematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation

发起方

OXXON Pharma AG