Safety, tolerability and pharmacokinetics of SSTK-101 in healthy volunteers
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
SKYDD Biotechnology Pty Ltd
38 participants
Oct 31, 2024
Interventional
Conditions
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.
Eligibility
Inclusion Criteria9
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Healthy male or female aged at least 18 years at the time of provision of written informed consent.
- Body weight at least 50 kg with a body mass index at least 18.0 and not greater than 32.0 kg/m2 (inclusive).
- Willing to use adequate contraception for the duration of the study.
- 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.
- Willing and able to read, understand, and sign the participant information and consent form.
Exclusion Criteria26
- Participants are excluded from the study if any of the following criteria apply:
- 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.
- Have positive hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus antibody testing at screening.
- 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.
- 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).
- 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.
- Are pregnant or lactating, or have a partner who is pregnant or lactating.
- Have an allergy to eggs or egg products.
- 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.
- 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.
- 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.
- 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.
- Taking, or have taken, any anti-viral drug in the 14 days prior to the first dose of
- investigational intervention.
- Received any vaccination within 14 days prior to the first dose of investigational
- intervention.
- 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.
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Interventions
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.
Locations(1)
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ACTRN12624001064594