Evaluation of the safety, tolerability, pharmacokinetics and pharmacodynamics of topically applied NT-077 (tiotropium bromide) in healthy volunteers. - CS0367-200494

otoxins Holding B.V.0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Male between 18 and 60 years of age (both inclusive) at the screening visit.
•2. Body mass index between 18 and 30 kg/m2. (both inclusive)
•3. Subject is judged to be in good health based on medical history, physical
•examination, vital sign measurements, and laboratory safety tests performed at
•the screening visit and prior to administration of the initial dose of study
•4. Willing to shave both axillaries prior and during the study
•5. Subject is willing to refrain from the use of antitransparant or
•antiperspirant sprays containing aluminum salts (e.g. Odorex extra dry, Syneo
•antitransparant spray and Odaban anti-transparent spray) from at least 7 days
•prior to first administration to and including the day of the last assessment
•of the last treatment period, and from the use of deodorant without aluminum
•salts from 24 hours prior to dosing until Day 2 during in the treatment periods
•of Part I and from Day 1 to 9 (including) in Part II.

•1. History of known sensitivity or intolerability to tiotropium bromide or to
•any related compound (including but not limited to ipratropium), or history of
•significant multiple and/or severe allergies (including latex allergy) or has
•had an anaphylactic reaction or significant intolerability to prescription or
•non-prescription drugs or food.
•2. History of clinically significant endocrine, gastrointestinal,
•cardiovascular, haematological, hepatic, immunological, renal, respiratory,
•neoplastic or genitourinary abnormalities or diseases. Subjects with a history
•of uncomplicated kidney stones or childhood asthma may be enrolled in the study
•at the discretion of the investigator.
•3. History of glaucoma or first line family members with glaucoma.
•4. Clinical significant history of skin diseases, including but not limited to
•5. Subjects suffering from primary hyperhidrosis.

发起方

otoxins Holding B.V.