A single center, open-label, repeated dose, Phase I study in healthy subjects to assess the safety, tolerability, pharmacokinetics and the effect on mobilization of hematopoietic stem cells of NOX-A12 alone and in combination with filgrastim. - SNOXA12C101

OXXON Pharma AG0 个研究点目标入组 12 人开始时间: 2011年6月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Healthy male or female subjects aged 18-55 years of any ethnic origin.
•Body weight between 50 and 100 kg (extremes included).
•Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory parameters.
•Females of non-childbearing potential, defined as surgically sterile or post-menopausal.
•Males willing to use 2 means of contraceptive methods for at least 3 months after test substance administration.
•Normal lung function (FVC and FEV1 at least 80% of predicted values) at screening.
•Written consent to participate in the study.

•Intake of vitamin A derivates or retinoids within 30 days prior to the start of drug administration.
•History of thrombosis.
•Chronic infection or acute infection or fever within the last 8 weeks prior to the start of drug administration.
•Subjects with a splenomegaly.
•Participation in another clinical study within three months prior to the start of drug administration.
•Blood donation (>100 ml) or a comparable blood loss within three months prior to the start of drug administration.
•Subjects who, in the investigator's opinion, may not be capable of following the study schedule for any reason.
•Subjects having already received G-CSF in the past.

发起方

OXXON Pharma AG