Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000676415
Ethics application status
Approved
Date submitted
19/05/2016
Date registered
24/05/2016
Date last updated
3/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase I study to evaluate the safety and tolerability of single and multiple doses of intranasal pentosan polysulfate (Rhinosul 'Trademark') in healthy subjects
Scientific title
Phase I study to evaluate the safety and tolerability of single and multiple doses of intranasal pentosan polysulfate (Rhinosul 'Trademark') in healthy subjects
Secondary ID [1] 289088 0
PARA_002
(Assigned Trial Protocol Number)
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 298548 0
Hay fever 298843 0
Condition category
Condition code
Respiratory 298631 298631 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 298632 298632 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 294598 0
Treatment: Drugs
Comparator / control treatment
Placebo controlled, double blinded, randomised.
The placebo is supplied as a nasal spray consisting of the vehicle, minus the active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 298142 0
Safety and tolerability.

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:
- General examination
- Vital signs
- ENT assessments
- Adverse events
Timepoint [1] 298142 0
Pre-dose and post-dose on the following days:

Day 1 (day 1 of dosing, single dose)
Day 2 (non dosing monitoring day)
Day 5 -11 (7 day repeat dose)
Day 12 (non dosing monitoring day)
Primary outcome [2] 298143 0
Safety assessment: 12-lead ECG monitoring
Timepoint [2] 298143 0
Pre-dose, and 1hr and 4hr post dose
Day 1, 5 and 11
Primary outcome [3] 298144 0
Safety - Blood results (haematology)
Timepoint [3] 298144 0
Day -1 baseline
Day 2, 4, 6, 12, 15
Secondary outcome [1] 323262 0
Safety assessment: measurement of APTT (Activated partial thromboplastin time - blood clotting time)
Timepoint [1] 323262 0
pre-dose, and then at, 2, 4, 6 and 8 hours following dosing on Days 1, 5 and 11
Secondary outcome [2] 324020 0
Primary Outcome
Safety - Blood results (Serum Biochemistry)
Timepoint [2] 324020 0
Day -1 baseline
Day 2, 4, 6, 12, 15

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated randomisation schedules will be prepared by a statistician prior to the start of the study. Subjects within a given dose level cohort will be randomised to receive Rhinosul or Placebo in a ratio of 2 to 1 respectively.
Subjects will then be allocated a corresponding pre-prepared bottle labelled with the same randomisation number. Bottles containing active and placebo will be indistinguishable apart from the randomisation number on the label
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedules will be prepared by a statistician prior to the start of the study for each dose level cohort
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Descriptive statistical analyses will be reported for all study endpoints by stage and sampling time within each dose. Results for those on placebo will be combined. Summary statistics for the categorical variables will include counts and percentages. The descriptive summary for the continuous variables will include number of subjects (n), means, medians, standard deviations, and minimum and maximum values. All data will be listed.
This study is descriptive in nature, and no formal hypothesis testing will be performed. Any confidence intervals (CIs) generated will be 95% using exact methods, unless stated otherwise.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2016
Actual
20/06/2016
Date of last participant enrolment
Anticipated
3/07/2016
Actual
4/07/2016
Date of last data collection
Anticipated
Actual
21/07/2016
Sample size
Target
18
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5702 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 13190 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 293475 0
Commercial sector/Industry
Name [1] 293475 0
Paradigm Biopharmaceuticals
Country [1] 293475 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Paradigm Biopharmaceuticals
Address
Level 2
517 Flinders Lane
Melbourne
VIC, 3000
Country
Australia
Secondary sponsor category [1] 292299 0
None
Name [1] 292299 0
Address [1] 292299 0
Country [1] 292299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294918 0
belberry ethics committee
Ethics committee address [1] 294918 0
Ethics committee country [1] 294918 0
Australia
Date submitted for ethics approval [1] 294918 0
20/04/2016
Approval date [1] 294918 0
25/05/2016
Ethics approval number [1] 294918 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65426 0
Dr Andrew Redfern
Address 65426 0
Linear Clinical Research Limited
1st Floor Block B, Hospital Ave
Nedlands,
WA 6009
Country 65426 0
Australia
Phone 65426 0
+61 8 6382 5100
Fax 65426 0
Email 65426 0
[email protected]
Contact person for public queries
Name 65427 0
Claire Kaufman
Address 65427 0
Paradigm BioPharmaceuticals Ltd
Level 2, 517 Flinders Lane
Melbourne VIC 3000
Country 65427 0
Australia
Phone 65427 0
+61 413421160
Fax 65427 0
Email 65427 0
[email protected]
Contact person for scientific queries
Name 65428 0
Claire Kaufman
Address 65428 0
Paradigm BioPharmaceuticals Ltd
Level 2, 517 Flinders Lane
Melbourne VIC 3000
Country 65428 0
Australia
Phone 65428 0
+61 413421160
Fax 65428 0
Email 65428 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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