None listed
Conditions
Brief summary
This is a randomised, double blind, placebo-controlled study in healthy subjects. As a phase 1 study, it is designed to evaluate the safety and tolerability of intranasal pentosan polysulfate sodium (Rhinosul 'Trademark') in healthy subjects, following single and repeat dose administration.
Interventions
Daily treatment with nasal spray, administered to subjects by Phase 1 unit clinical staff
Two dose levels to be evaluated in 2 cohorts in an ascending dose design
Study medication (Pentosan polysulfate sodium nasal spray) will be administered once daily to 2 groups of participants (40 mg cohort and 80 mg cohort) in 2 sequential stages, A safety review will be conducted before each dose escalation
Stage 1 - Single dose (2 sprays per nostril, once a day) on day 1
Stage 2 - 7 day multiple dose (2
Daily treatment with nasal spray, administered to subjects by Phase 1 unit clinical staff Two dose levels to be evaluated in 2 cohorts in an ascending dose design Study medication (Pentosan polysulfate sodium nasal spray) will be administered once daily to 2 groups of participants (40 mg cohort and 80 mg cohort) in 2 sequential stages, A safety review will be conducted before each dose escalation Stage 1 - Single dose (2 sprays per nostril, once a day) on day 1 Stage 2 - 7 day multiple dose (2 sprays per nostril, once a day) on days 5-11 Subjects will be admitted to the Phase 1 unit on day -1, and confined to the unit for the duration of dosing, including monitoring days where no treatment is given (day 2, 3, 4, and 12).
Sponsors
Paradigm Biopharmaceuticals
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able to speak, read and understand English sufficiently to understand the purposes and risks of the study and to provide written informed consent. 2. Healthy males or females aged 18 to 65 years inclusive at the time of consent. 3. Body Mass Index (BMI) of greater than or equal to 18.0, and less than or equal to 32.0 kg/m2 4. Normal nasal examination as per Ear, Nose and Throat (ENT) assessment 5. Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 6. Suitable venous access 7. Subjects who are a. females of non child-bearing potential OR b. females who are not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study c. males who are willing to comply with the medically acceptable contraceptive requirements of the study
Exclusion criteria
1. Medical history or clinically significant disease as judged by the investigator or sponsor 2. History of idiopathic nose bleeds, more frequently than once in the previous 12 months 3. Subjects who have a positive urine cotinine test at Screening or Day -1. 4. Smokers (i.e. no cigarette or tobacco use at any time during the last 12 months) 5. 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. 6. Use of prescription or non-prescription (over-the-counter) or complementary medicines, within 14 days prior to Day -1, 7. Respiratory tract infection within the previous four weeks or any infection within 7 days prior to Day -1. 8. 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). 9. Activated partial thromboplastin time (APTT) outside normal range 10.Clinically significant abnormality of renal function as judged by the investigator or sponsor 11.Clinically significant abnormality of hepatic function 12.History or evidence of, or positive test for HIV, hepatitis B or hepatitis C. 13.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. 14.Administration of any investigational agent within 8 weeks or 5 half-lives (whichever is longer) prior to Day -1. 15.History of significant hypersensitivity to any of the IMPs or drugs of a similar class. 16.Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion. 17.Major surgery within 3 months prior to Day -1 or anticipated surgery in the study period. 18.Blood or plasma donation of more than 500 mL during the 3 months prior to Day -1. 19.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. 20.History of fainting during phlebotomy 21.Unable to refrain from strenuous activity 48 hours prior to Day -1 and for the duration of the study.
Outcome results
None listed