A randomized, double-blind, placebo-controlled, parallel-groups, intranasal dose escalating study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of compound S0597 by intranasal route in healthy male subjects

Sun Pharma Advanced Research Company Ltd0 个研究点目标入组 40 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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•Availability of subject for the entire study period and willingness to adhere to protocol requirements.
•Healthy male subjects, 18 through 45 years of age, subjects having weight at least 50Kg and the subjectâ??s body mass index (BMI) must be within 18.5 â?? 25.0 (Kg/m2) (inclusive).
•Morning basal serum cortisol value within the normal range of 8 to 25 mcg/dL, inclusive.
•Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21days prior to commencement of the study.
•Subjects whose screening laboratory values are within normal limits or considered by the Principal Investigator/Sub-Investigator to be of no clinical significance.
•Subjects, who are able to demonstrate that they are able to perform the dosing technique properly after training and evaluation on use of the nasal spray by using a placebo spray bottle.
•Informed consent form given in written form

•1.FEV1 ≤80% of predicted normal value
•2.History or presence of significant:
•2.1Difficulty in taking intranasal spray.
•2.2Ear-nose-throat disease, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
•2.3Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
•2.4Smoking (more than or equal to 10 cigarettes/day) or consumption of tobacco products (> 4 chews/day).
•2.5Positive result to HIV, HBsAg, HCV, or VDRL/RPR.
•2.6Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study.
•3.Donation of 350 ml or more of blood in the previous 90 days before day 1 of this study.
•4.Participation in another clinical study within the preceding 90 days of study starts.
•5.Subjects who have:
•5.1Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
•5.2Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4mm Hg) at check-in may be acceptable at the discretion of the clinical investigator.
•5.3Pulse rate below 60/min. or above 100/min.

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