A Phase I clinical study of intravenous administration of AntiPlatelet, AntiCoagulant (APAC) in healthy subjects.

Cadila Pharmaceutical Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•1.Healthy subjects of either gender with >=18 and <=45 years of age.
•2.Subjects able to understand and provide the written informed consent.
•3.Subject willing to follow study schedules and all requirements of the study, in the PI/investigatorâ??s opinion.
•4.Female subjects of childbearing potential having a negative urine pregnancy test prior to first dose of APAC.

•1.Subjects with symptoms of fever or active infection, hemoglobin levels <= 11 g/dL, thrombocytopenia, (platelet count < 100,000/cmm).
•2.Subjects with a history of known sensitivity to heparin.
•3.Subjects with an abnormal APTT, PT, TT, ACT, platelet aggregation studies, fibrinogen, D-dimer, anti-Factor IIa activity, anti-Factor Xa activity and/or abnormal or prolonged ROTEM, VWF:Ag, FVIII or AT-III value(s) at Screening.
•4.Subject taking any prescription drugs or over the counter (OTC) medications, including herbal and ayurvedic medications at Screening.
•5.Subjects with any other medical condition (a bleeding disorder), including any evidence of HIT, which in the opinion of the PI/investigator, should exclude them from the study.
•6.Concurrent involvement in any other clinical study with an investigational drug or device, or participation in a clinical study within 30 days prior to entering the study.
•7.Female subjects who are pregnant, lactating or of childbearing potential and unwilling or unable to use adequate contraception.
•8.Subjects who for any reason, in the PI/investigatorâ??s opinion, are unsuitable for enrolment into the study.

发起方

Cadila Pharmaceutical Limited