None listed
Conditions
Brief summary
This is a 2 stage study consisting of an initial open label study in ten (10) healthy volunteers to assess safety and iodine adsorption followed by a randomised, double blind, placebo controlled efficacy study in 258 participants exhibiting the common cold.
Interventions
Intervention is an aqueous buffered solution of povidone-iodine (PVP-I) or matching placebo contained in a 30 mL bottle closed with a traditional nasal spray pump.
This 2 stage study consists of:
Stage 1: An open-label Phase 1 study in ten (10) healthy volunteers at a single site to investigate safety and iodine adsorption. Participants will receive a total of 21 doses, over 6 days; 4 times on Days 1,2,3,4,5 and 1 time on the morning of Day 6. 1 dose consists of 8 x 140µL pump actuation's (4 in
Intervention is an aqueous buffered solution of povidone-iodine (PVP-I) or matching placebo contained in a 30 mL bottle closed with a traditional nasal spray pump. This 2 stage study consists of: Stage 1: An open-label Phase 1 study in ten (10) healthy volunteers at a single site to investigate safety and iodine adsorption. Participants will receive a total of 21 doses, over 6 days; 4 times on Days 1,2,3,4,5 and 1 time on the morning of Day 6. 1 dose consists of 8 x 140µL pump actuation's (4 into each nostril). Each dose will be administered in approximately 4 hour intervals. Stage 2: a two site, randomised, double-blind, placebo-controlled safety and efficacy study in 258 participants exhibiting the common cold. Participants will receive a total of 21 doses, over 5-6 days; the time that a participant is dosed on Day 1 will determine how many doses per day will be required. 1 dose consists of 8 x 140µL pump actuation's (4 into each nostril). Each dose will be administered in approximately 4 hour intervals. The adherence of dosing in both stages will be monitored by the return of the used product and via diary entries in a dosing diary in Stage 1, and via a webapp diary in Stage 2.
Sponsors
Firebrick Pharma Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Stage 1: 1. A healthy adult (18-55 years old) 2. Exhibit as no clinically relevant abnormalities as determined by past medical history, physical examination, vital signs, and laboratory tests at Screening. 3. Female subjects of childbearing potential must have a confirmed negative pregnancy test at the start of the study (Screening and Day -1) and also agree to abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study and for 90 days after last dose of study drug, as determined by the investigator. Female participants of non-childbearing potential, defined as surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or clinically documented to be postmenopausal. 4. Male subjects must agree to abstain from sexual intercourse or use a highly effective method of birth control with partners of childbearing potential for the duration of the study and for 90 days after last dose of study drug. Stage 2: 1. Adult (18-65) participants who have a cold or are coming down with a cold 2. Report at least two of the following cold symptoms – sneezing, runny nose, nasal congestion, or sore throat – and have a total Jackson score of at least 6 points. Jackson scores are simple sums of severity ratings (0 = absent, 1 = mild, 2 = moderate, 3 = severe). 3. Have had cold symptoms for at least 24 hours at the time they commence treatment. 4. Access to a smartphone or tablet. 5. Female subjects of childbearing potential must have a confirmed negative pregnancy test at the start of the study (Screening and Day -1) and also agree to abstain from sexual intercourse or use a highly effective method of birth control for the duration of the study and for 90 days after last dose of study drug, as determined by the investigator. Female participants of nonchildbearing potential, defined as surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or clinically documented to be postmenopausal. 6. Male subjects must agree to abstain from sexual intercourse or use a highly effective method of birth control with partners of childbearing potential for the duration of the study and for 90 days after last dose of study drug.
Exclusion criteria
Stage 1: 1. Upper respiratory tract infection in the 4 weeks prior to the first dose of investigational product 2. Visited a doctor in the previous 48 hours and had a diagnosis of allergic rhinitis, bacterial sinusitis or LRTI 3. Fever (>38 degrees Celsius), tachycardia greater than or equal to 100 bpm, bradycardia less than or equal to 50 bpm, BP greater than or equal to 160 systolic or greater than or equal to 110 diastolic or BP less than or equal to 100 systolic or less than or equal to 50 diastolic, respiratory rate greater than or equal to 20 breaths per minute 4. Using or intending to use a povidone-iodine gargle during the study 5. Previous diagnoses of nasal polyps or any ear, nose and throat pathology deemed by the Principal Investigator or delegate to affect assessment of the investigational product 6. Known iodine sensitivity 7. Previous diagnosis of thyroid disease/dysfunction 8. Pregnant or nursing (lactating) or planning to become pregnant 9. Detected illicit drug use or under the influence of alcohol 10. Use of systemic decongestants, decongestant nasal sprays or any other intranasal drugs or medications in the 4 weeks prior to the first dose of investigational product 11. Subject with presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment Stage 2: 1. Visited a doctor in the previous 48 hours and had a diagnosis of allergic rhinitis, bacterial sinusitis or LRTI 2. Fever (>38 degrees Celsius ), tachycardia greater than or equal to 100 bpm, bradycardia less than or equal to 50 bpm, BP greater than or equal to 160 systolic or greater than or equal to 110 diastolic or BP less than or equal to 100 systolic or less than or equal to 50 diastolic, respiratory rate greater than or equal to 20 breaths per minute 3. Lower respiratory tract infection signs or symptoms 4. Is considered too unwell based on global medical assessment 5. Self-reporting of normally very mild cold symptoms with a common cold, including duration of illness of < 48 hours 6. Previous diagnoses of nasal polyps or any ear, nose and throat pathology deemed by the Principal Investigator or delegate to affect assessment of the investigational product 7. Previous diagnoses of any chronic respiratory diseases, including asthma, chronic cough, COPD etc. 8. Known immunodeficiency 9. Known iodine sensitivity 10. Previous diagnosis of thyroid disease/ dysfunction 11. Pregnant or nursing (lactating) or planning to become pregnant 12. Any medical condition deemed by the Principal Investigator or delegate to affect assessment of the investigational product 14. Participated in another clinical trial within the past 30 days 15. Using or intending to use a povidone-iodine gargle during the study 16. Taking any OTC cold medications/complementary or herbal products or intending to do so (paracetamol will be available as rescue medication for disabling symptoms) 17. Detected illicit drug use or under the influence of alcohol as determined by routine diagnostic assays
Outcome results
None listed