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

Phase 1

Completed

• Conditions: Inflammatory and Immune System - Allergies; Respiratory - Other respiratory disorders / diseases; Allergic Rhinitis; Hay fever

• Registration Number: ACTRN12616000676415
• Lead Sponsor: Paradigm Biopharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability.<br><br>Qualified medical staff in the trial unit will conduct daily general physical examinations on dosing days, and on the day subsequent to dose cessation. The following will be assessed:<br>- General examination<br>- Vital signs<br>- ENT assessments<br>- Adverse events [Pre-dose and post-dose on the following days: <br><br>Day 1 (day 1 of dosing, single dose)<br>Day 2 (non dosing monitoring day)<br>Day 5 -11 (7 day repeat dose)<br>Day 12 (non dosing monitoring day)];Safety assessment: 12-lead ECG monitoring[Pre-dose, and 1hr and 4hr post dose<br>Day 1, 5 and 11];Safety - Blood results (haematology)[Day -1 baseline<br>Day 2, 4, 6, 12, 15]

Secondary Outcome Measures

Name	Time	Method
Safety assessment: measurement of APTT (Activated partial thromboplastin time - blood clotting time)[pre-dose, and then at, 2, 4, 6 and 8 hours following dosing on Days 1, 5 and 11];Primary Outcome<br>Safety - Blood results (Serum Biochemistry)[Day -1 baseline<br>Day 2, 4, 6, 12, 15]