Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001371987
Ethics application status
Approved
Date submitted
7/12/2020
Date registered
22/12/2020
Date last updated
22/06/2022
Date data sharing statement initially provided
22/12/2020
Date results provided
22/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, double-blind, placebo-controlled investigation of the safety, tolerability and pharmacokinetics of 1% SPL7013 nasal spray in healthy volunteers when administered four times a day for 14 days
Scientific title
A randomized, double-blind, placebo-controlled investigation of the safety, tolerability and pharmacokinetics of 1% SPL7013 nasal spray in healthy volunteers when administered four times a day for 14 days
Secondary ID [1] 302923 0
SPL7013-021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 319940 0
Condition category
Condition code
Infection 317879 317879 0 0
Other infectious diseases
Respiratory 318061 318061 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1% SPL7013 Nasal Spray
0.1 mL in each nostril, self-administered at home 4 times daily for 14 days
Intranasal
Adherence to intervention will be monitored via return and weight check of nasal spray bottles
Intervention code [1] 319208 0
Prevention
Comparator / control treatment
Placebo Nasal Spray (identical to SPL7013 Nasal Spray without SPL7013)
0.1 mL in each nostril, self-administered at home 4 times daily for 14 days
Intranasal
Adherence to placebo will be monitored via return and weight check of nasal spray bottles
Control group
Placebo

Outcomes
Primary outcome [1] 325895 0
Frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), including nasal cavity examination findings, physical examination findings, abnormal clinically significant vital signs (body temperature, heart rate, respiratory rate, blood pressure), 12-lead electrocardiograms (ECGs) and laboratory parameters (hematology, coagulation, chemistry and urinalysis/urine microscopy)
Timepoint [1] 325895 0
Day 1, Day 7, Day 15 and Day 21 (telephone follow-up only) post first dose
Secondary outcome [1] 389454 0
SPL7013 plasma concentration and, if detected in plasma, the AUC, Cmax, and half-life of SPL7013 assessed from plasma samples
Timepoint [1] 389454 0
15 min prior to and 0.25, 0.5, 1, 2, 3 and 4 hours post first dose on Day 1, and 15 min prior to and 0.25, 0.5, 1, 2, 3 and 4 hours after one of the doses (1st, 2nd, 3rd or 4th dose, depending on visit timing and availability of site staff) on Day 7.

Eligibility
Key inclusion criteria
1. Male and female, aged 18 to 65 years, inclusive.
2. In good general health, with no significant medical history, no clinically significant abnormalities on physical examination at screening and/or before administration of the initial application of the investigational device.
3. Body Mass Index (BMI) between 18.0 and 32.0 kg/sqm, inclusive.
4. Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate.
5. Non-smoker and must not have used any nicotine containing products within 2 months prior to screening.
6. Written informed consent signed prior to entry into the investigation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Prior or ongoing medical condition, medical history, physical findings or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the participant.
2. Abnormal and/or clinically significant findings upon examination of the nasal cavity .
3. Has received an investigational drug, other investigational device, or approved therapy for investigational use within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.
4. Pregnant or breastfeeding.
5. Fever (body temperature >=38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening.
6. Known allergy to SPL7013 or any of the spray components
7. Participant has used any kind of nasal product within 7 days prior to the start of the investigation, and/or the use of nasal products during the investigation is anticipated.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2021
Actual
6/01/2021
Date of last participant enrolment
Anticipated
5/02/2021
Actual
8/03/2021
Date of last data collection
Anticipated
28/02/2021
Actual
29/03/2021
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 307345 0
Commercial sector/Industry
Name [1] 307345 0
Starpharma Pty Ltd
Country [1] 307345 0
Australia
Funding source category [2] 309112 0
Other Collaborative groups
Name [2] 309112 0
Biomedical Translation Bridge program, delivered by MTPConnect
Country [2] 309112 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Starpharma Pty Ltd
Address
4-6 Southampton Crescent
Abbotsford VIC 3067
Country
Australia
Secondary sponsor category [1] 307984 0
None
Name [1] 307984 0
Address [1] 307984 0
Country [1] 307984 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307432 0
Bellberry Ltd
Ethics committee address [1] 307432 0
Ethics committee country [1] 307432 0
Australia
Date submitted for ethics approval [1] 307432 0
07/12/2020
Approval date [1] 307432 0
21/12/2020
Ethics approval number [1] 307432 0

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

Contacts
Principal investigator
Name 107218 0
Dr Jasmine Williams
Address 107218 0
Linear Clinical Research
Level 1, B Block
Hospital Avenue
Nedlands WA 6009
Country 107218 0
Australia
Phone 107218 0
+61 8 6382 5100
Fax 107218 0
Email 107218 0
[email protected]
Contact person for public queries
Name 107219 0
Jeremy Paull
Address 107219 0
Starpharma Pty Ltd
4-6 Southampton Crescent
Abbotsford VIC 3067
Country 107219 0
Australia
Phone 107219 0
+61 3 8532 2736
Fax 107219 0
Email 107219 0
[email protected]
Contact person for scientific queries
Name 107220 0
Jeremy Paull
Address 107220 0
Starpharma Pty Ltd
4-6 Southampton Crescent
Abbotsford VIC 3067
Country 107220 0
Australia
Phone 107220 0
+61 3 8532 2736
Fax 107220 0
Email 107220 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data are commercial-in-confidence and are not able to be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAstodrimer sodium antiviral nasal spray for reducing respiratory infections is safe and well tolerated in a randomized controlled trial.2022https://dx.doi.org/10.1038/s41598-022-14601-3
N.B. These documents automatically identified may not have been verified by the study sponsor.