None listed
Conditions
Brief summary
Starpharma is developing a nasal spray intended to inactivate severe acute respiratory virus 2 (SARS-CoV-2), the virus that causes coronavirus disease of 2019 (COVID-19). The nasal spray contains 1% w/w SPL7013, a molecule with broad spectrum antiviral and virucidal activity. SPL7013 is able to physically block SARS-CoV-2 attachment to cells and therefore inhibit infection. The primary objective of this clinical investigation is to assess the safety and tolerability of 1% SPL7013 Nasal Spray applied to the nasal mucosa of healthy volunteers 4 times a day for 14 days.
Interventions
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
Sponsors
Starpharma Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed