ACTRN12616000676415
Completed
Phase 1
Phase I study to evaluate the safety and tolerability of single and multiple doses of intranasal pentosan polysulfate (Rhinosul 'Trademark') in healthy subjects
Paradigm Biopharmaceuticals0 sites18 target enrollmentMay 24, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Allergic Rhinitis
- Sponsor
- Paradigm Biopharmaceuticals
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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