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Trial registered on ANZCTR


Registration number
ACTRN12624001064594
Ethics application status
Approved
Date submitted
24/06/2024
Date registered
3/09/2024
Date last updated
3/09/2024
Date data sharing statement initially provided
3/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety, tolerability and pharmacokinetics of SSTK-101 in healthy volunteers
Scientific title
Randomised, double-blind, placebo-controlled, single-centre investigation of the safety, tolerability and pharmacokinetics of 0.03% SSTK-101 nasal and oral spray as single or multiple administrations in healthy volunteers
Secondary ID [1] 311250 0
SSTK-101-001 Anti Covid Spray
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of COVID 19 334987 0
Condition category
Condition code
Infection 329164 329164 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.03% SSTK-101 is administered via a spray dosage in Part 1 and Part 2 of the study. With a study observation interval of 1 week, between Part 1 and Part 2 of the study.

Part 1
2 sprays in the mouth and 2 sprays in each nostril for an approximate dose of 0.6 mL (0.03% SSTK-101) for the single dose part of the study. Single dose in Part 1 with supervised self-administration initially in Clinic then self-administration at home.
Following Part 1, the one-week observation period commences.
Part 2
Is the multiple dose part of the study with administration 4 times daily dose, 2 sprays in the mouth and 2 sprays in each nostril for an approximate dose of 0.6 mL (0.03% SSTK-101) at 4 hourly intervals for 14 days with supervised self-administration initially in Clinic, then administration at home.
Adherence will be monitored using a participant dosing diary in both stages.
Participants may be able to participate in Part 1 and Part 2.
Intervention code [1] 327705 0
Prevention
Comparator / control treatment
The active study intervention is 0.03% Anti-SARS-CoV-2 IgY Antibody in
phosphate buffered saline.
The Placebo treatment is saline.
2 sprays in the mouth and 2 sprays in each nostril.
Single dose in Part 1 with supervised self-administration.
4 times daily dose for 14 days in Part 2 with self-administration at home
Adherence will be monitored using a participant dosing diary
Control group
Placebo

Outcomes
Primary outcome [1] 336992 0
Safety of 0.03% SSTK-101 administered as a single dose or multiple doses (4 times daily for 14 days) in healthy volunteers. Multiple checking points of assessment prior, during and post Clinical Trial.
Timepoint [1] 336992 0
Timepoints at each interval below :
Interval Times
Single dose Part 1: Day 1, Day 2, Day 3 and Day 8 post dose.
Multiple dose Part 2: Day 1, Day 2, Day 14, Day 16 and Day 21 post dose.

The following tests are completed:
Total Nasal Symptom Score (TNSS)
University of Pennsylvania Smell Identification Test (UPSIT)
Nasal and mouth cavity examination
Clinical laboratory tests (haematology, biochemistry, urinalysis and coagulation)
Vital signs - (temperature, breathing, blood pressure, oxygen saturation - utilising thermometer, Spirometer, Blood pressure Monitor, Oximeter)
12-lead electrocardiogram (ECG)
Physical examination
Primary outcome [2] 339178 0
Tolerability of 0.03% SSTK-101 administered as a single dose or multiple doses (4 times daily for 14 days) in healthy volunteers. Multiple checking points of assessment prior, dureing, and post Clinical Trial.
Timepoint [2] 339178 0
Time points at each interval below :
Interval Times
Single dose Part 1: Day 1, Day 2, Day 3 and Day 8 post dose.
Multiple dose Part 2: Day 1, Day 2, Day 14, Day 16 and Day 21 post dose.

The following tests are completed:
Total Nasal Symptom Score (TNSS)
University of Pennsylvania Smell Identification Test (UPSIT)
Nasal and mouth cavity examination
Clinical laboratory tests (haematology, biochemistry, urinalysis and coagulation)
Vital signs - (temperature, breathing, blood pressure, oxygen saturation - utilising thermometer, Spirometer, Blood pressure Monitor, Oximeter)
12-lead electrocardiogram (ECG)
Physical examination
Primary outcome [3] 339179 0
Effectiveness of 0.03% SSTK-101 administered as a single dose or multiple doses (4 times daily for 14 days) in healthy volunteers to act as a preventative for COVID 19.
Multiple checking points of assessment prior during and post Clinical Trial.
Timepoint [3] 339179 0
Timepoints at each interval below :
Interval Times
Single dose Part 1: Day 1, Day 2, Day 3 and Day 8 post dose.
Multiple dose Part 2: Day 1, Day 2, Day 14, Day 16 and Day 21 post dose.

The following tests are completed:
TGA approved 4 in 1 Multi Test for COVID, Influenza A&B and RSV
Total Nasal Symptom Score (TNSS)
University of Pennsylvania Smell Identification Test (UPSIT)
Nasal and mouth cavity examination
Clinical laboratory tests (haematology, biochemistry, urinalysis and coagulation)
Vital signs - (temperature, breathing, blood pressure, oxygen saturation - utilising thermometer, Spirometer, Blood pressure Monitor, Oximeter)
12-lead electrocardiogram (ECG)
Physical examination
Secondary outcome [1] 430337 0
Pharmacokinetics (PK) of 0.03% SSTK-101 administered as a single dose or multiple doses (4 times daily each for 14 days) in healthy volunteers,
Timepoint [1] 430337 0
Day 1 blood samples taken pre-dose (-10 mins), and post dose at 1 hour (±15 mins), 2 hours (± 15 mins) and 24 hours (±1 hour). Further blood samples will be taken at Day 2 and Day 8 for participants in the single dose Part 1, and at Day 2, Day 14 and Day 21 for participants in the multiple dose Part 2.
Secondary outcome [2] 436695 0
Assessment of participants contracting COVID 19 during the trial period, results recorded as part of trial.
Timepoint [2] 436695 0
The 4 in 1 testing to be completed by participants prior to participating in trial and then 2nd , 4th, 6th, 8th, 10th, 12th, 14, 16, 18 day during the trial period with the final test undertaken on the final day. (day 21 of initial dose)

Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:

1. Healthy male or female aged at least 18 years at the time of provision of written informed consent.

2. Body weight at least 50 kg with a body mass index at least 18.0 and not greater than 32.0 kg/m2 (inclusive).

3. Willing to use adequate contraception for the duration of the study.

4. In the opinion of the Investigator, is in a good state of health, as indicated by a
comprehensive clinical assessment (detailed medical history and a complete physical
examination), electrocardiogram (ECG), vital signs, and laboratory investigations.
(haematology, clinical chemistry, coagulation, and urinalysis) and be able to participate in all scheduled evaluations, likely to complete all required tests, and likely to be compliant with all.

6. Willing and able to read, understand, and sign the participant information and consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:

1. Have received any investigational drug or device in a clinical research study within the
previous 30 days prior to screening or 5 half-lives for investigational drug, whichever is
longer.

2. Have positive hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus antibody testing at screening.

3. Are current smokers of e-cigarettes or nicotine products and those who have used on average more than 3 of these products per month within the last 6 months.

4. Have a history of or active drug or alcohol abuse in the past 2 years (defined as more than 10 standard drinks per week (100 g pure alcohol) per week or 4 standard drinks per day on
average; where 1 standard drink contains 10 g alcohol, for example ~250 mL beer, 100 mL
red wine, 30 mL spirits (Alcohol and Drug Foundation, 2023; Australian Government
Department of Health and Aged Care, 2023).

5. Have a positive urine drug test at screening or admission (amphetamines, barbiturates,
benzodiazepines, cannabinoids, cocaine and opiates) and/or a positive alcohol breath test at screening or during the inpatient period.

6. Are pregnant or lactating, or have a partner who is pregnant or lactating.

7. Have an allergy to eggs or egg products.

8. Have a known or suspected autoimmune disease or impairment / alteration of immune
function resulting from congenital or acquired immunodeficiency, or receipt of
immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, and other immunosuppressive therapy as per investigator discretion.

9. History of nasal surgical procedures (e.g. turbinectomy, rhinoplasty etc), or a history of
recurrent nose bleeds, rhinitis, sinusitis, or oral infections or injuries of any type.

10. Have clinically significant allergic, haematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological disease that would prevent the participant from participating in the study, including the presence of laboratory abnormalities that may place the participant at unacceptable risk if they were to participate in the study.

11. Taking, or have taken, any prescribed or over-the-counter drug (other than paracetamol, or hormone replacement therapy and hormonal contraception) or herbal remedies in the 14 days prior to the first dose of investigational intervention. Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as agreed by the principal investigator and sponsor’s medical monitor.

12. Taking, or have taken, any anti-viral drug in the 14 days prior to the first dose of
investigational intervention.

13. Received any vaccination within 14 days prior to the first dose of investigational
intervention.

14. Have a positive SARS-CoV-2 test or Influenza A or B or RSV by PCR or Rapid Antigen Test within 12 weeks of screening.

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)
numbered dispensers which identify batches
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Randomisation by ballot selection
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 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2024
Actual
Date of last participant enrolment
Anticipated
22/11/2024
Actual
Date of last data collection
Anticipated
2/12/2024
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315506 0
Commercial sector/Industry
Name [1] 315506 0
SKYDD Biotechnology Pty Ltd
Country [1] 315506 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
SKYDD Biotechnology Pty Ltd
Address
151 Sturt Street, Southbank Victoria
Country
Australia
Secondary sponsor category [1] 317587 0
None
Name [1] 317587 0
Address [1] 317587 0
Country [1] 317587 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314409 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 314409 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 314409 0
Australia
Date submitted for ethics approval [1] 314409 0
19/12/2023
Approval date [1] 314409 0
14/03/2024
Ethics approval number [1] 314409 0

Summary
Brief summary
SSKI-101 is a novel anti-SARS-CoV-2 IgY antibody spray that has been developed as a Class 3 - Medical Device under the TGA guidelines.
It is for use 4 times daily through self-administration in the nose and mouth for prevention of COVID-19 in adults. The IgY neutralizing antibody is obtained from the egg yolk of hens immunised with a purified recombinant SARS-CoV-2 extracellular domain of the spike protein (S-ECD).
SSKI-101 has the potential to prevent infection with SARS-CoV-2 by acting as a barrier to the virus entering the body through cells in the nose and mouth. Initial human studies have been undertaken and have been positive thus far.
This human healthy volunteer Clinical study is designed to determine the safety and tolerability of SSTK-101 when administered in the nose and mouth and also to investigate whether SSTK-101 is absorbed systemically following administration to the nasal cavity and mouth. It is also being completed to assess further the preventative results.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131478 0
Prof Prof James Mc Carthy
Address 131478 0
C/- Doherty Institute, 792 Elizabeth Street Melbourne, Vic 3000
Country 131478 0
Australia
Phone 131478 0
+61 03 8344 0927
Fax 131478 0
Email 131478 0
[email protected]
Contact person for public queries
Name 131479 0
Mr. Nigel Blair
Address 131479 0
Medical Products Hub, 1 Oxley Road, Hawthorn, Victoria 3122
Country 131479 0
Australia
Phone 131479 0
+61 418208436
Fax 131479 0
Email 131479 0
[email protected]
Contact person for scientific queries
Name 131480 0
Dr David Kingston
Address 131480 0
D J Medical P/l, 1015/20 Pelican St Surry Hills NSW 2010
Country 131480 0
Australia
Phone 131480 0
+61 408 444 814
Fax 131480 0
Email 131480 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


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
No additional documents have been identified.