An open label study to investigate safety, tolerability and acceptability of needle free injection system in healthy volunteers in comparison to conventional needle-based system.

IntegriMedical0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male or female in the age group 18 to 45 years both inclusive
•Able and willing to sign the informed consent form
•Physical examination without clinically significant findings
•Hemoglobin in the opinion of a PI as clinically not significant
•WBC and differential in the opinion of a PI as clinically not significant
•No history of liver disorders in past 3 months
•No history of kidney disorders in past 3 months
•No history of cardiovascular disorders in past 3 months
•No history of neurological disorders in past 3 months
•Negative human chorionic gonadotropin (beta-HCG) pregnancy test (urine) on day of enrollment
•In good general health without clinically significant medical history and based on clinical judgement of principal investigator

•Breast-feeding women
•More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment
•Blood products within 16 weeks prior to enrollment
•Bleeding disorder history (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM, SC injection or blood draws
•Investigational research products within 4 weeks prior to enrollment or planning to receive investigational products while on the study
•Asthma that is not well controlled
•Diabetes mellitus (type I or II)
•Evidence of autoimmune disease or immunodeficiency
•Idiopathic urticaria within the past year
•Hypertension that is not well controlled
•Malignancy that is active or history of malignancy
•Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteerâ??s ability to give informed consent

发起方

IntegriMedical