Phase I study to evaluate the safety and tolerability of single and multiple doses of intranasal pentosan polysulfate (Rhinosul 'Trademark') in healthy subjects

Exclusion Criteria21

• Medical history or clinically significant disease as judged by the investigator or sponsor
• History of idiopathic nose bleeds, more frequently than once in the previous 12 months
• Subjects who have a positive urine cotinine test at Screening or Day -1.
• Smokers (i.e. no cigarette or tobacco use at any time during the last 12 months)
• Use of caffeine-containing foods/beverages/dietary supplements, or alcohol within 24 hours prior to admission to Day -1 and/or unable to refrain from their use during the study.
• Use of prescription or non-prescription (over-the-counter) or complementary medicines, within 14 days prior to Day -1,
• Respiratory tract infection within the previous four weeks or any infection within 7 days prior to Day -1.
• Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead ECG, or vital signs as judged by the investigator or sponsor (at Screening and/or Day -1).
• Activated partial thromboplastin time (APTT) outside normal range
• Clinically significant abnormality of renal function as judged by the investigator or sponsor
• Clinically significant abnormality of hepatic function
• History or evidence of, or positive test for HIV, hepatitis B or hepatitis C.
• Positive urine drug screen or alcohol test during Screening or on Day -1, or history of drug or alcohol abuse and/or dependence within the year prior to Day -1.
• Administration of any investigational agent within 8 weeks or 5 half-lives (whichever is longer) prior to Day -1.
• History of significant hypersensitivity to any of the IMPs or drugs of a similar class.
• Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion.
• Major surgery within 3 months prior to Day -1 or anticipated surgery in the study period.
• Blood or plasma donation of more than 500 mL during the 3 months prior to Day -1.
• History of, or current clinically-significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunological, neurological, ophthalmological, haematological or psychiatric disorder or any other condition, which in the opinion of the investigator or sponsor would jeopardize the safety of the participant or the validity of the study results.
• History of fainting during phlebotomy
• Unable to refrain from strenuous activity 48 hours prior to Day -1 and for the duration of the study.