None listed
Conditions
Brief summary
This project is testing the safety, tolerability and brain delivery of INB-01, an intranasal formulation of a currently marketed MRI contrast agent. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. Participants will be randomised (assigned randomly, like flipping a coin) to one of two stages. In Stage 1 you will receive a single intranasal dose of placebo. In Stage 2 you will receive a single intranasal dose of INB-01, the active experimental contrast agent. It is hoped that this research will help determine the safety of INB-01 when given to healthy men or women and to see if it gets to the brain tissues
Interventions
Approximately 12 healthy men or women will be enrolled into this study. They will be randomised in a 1:5 fashion between the two stages of the study.
In Stage 1, 2 healthy men and women will receive a single intranasal dose of placebo. The dose is divided into 2 sprays per nostril. Each spray is 140 µL for a total volume per nostril of 280 µL and a total overall volume per dose of 560 µL. The dose will be administered by a doctor. The participants will be observed in the clinic for 4 hour
Approximately 12 healthy men or women will be enrolled into this study. They will be randomised in a 1:5 fashion between the two stages of the study. In Stage 1, 2 healthy men and women will receive a single intranasal dose of placebo. The dose is divided into 2 sprays per nostril. Each spray is 140 µL for a total volume per nostril of 280 µL and a total overall volume per dose of 560 µL. The dose will be administered by a doctor. The participants will be observed in the clinic for 4 hours. If there are no tolerability concerns in Stage 1, then 10 healthy men and women in Stage 2 will receive a single intranasal 37 mg dose of INB-01 which is an intranasal form of gadolinium, an active contrast agent. The dose is divided into 2 sprays per nostril. Each spray is 140 µL for a total volume per nostril of 280 µL and a total overall volume per dose of 560 µL. The dose will be administered by a doctor. The participants will be observed in the clinic for 6 hours during which time they will have 5 MRI scans of the brain conducted by a radiologist.
Sponsors
InnarisBio Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participants must be: a. Of non-childbearing potential, or b. If of childbearing potential, be non-pregnant and not lactating and agree to use highly effective contraception, not become pregnant and not donate eggs from screening through 30 days post dose, or c. If male, if engaging in sexual intercourse with a partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days post-last dose and agree not to donate sperm during this period. 2. Judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and/or before first dose. 3. Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 with a weight greater than or equal to 50 kg at time of screening. 4. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments. 5. Willing and able to provide written informed consent.
Exclusion criteria
1. Has a deformity of the nasal cavity, a known deviation of the nasal septum; current symptoms of hay fever, acute or chronic sinusitis or recent history of surgery of the nasal cavity and/or nasopharynx, atrophic rhinitis or a history or presence of any anatomical or medical condition that might impede delivery or absorption of the intranasal investigational product. 2. Use of intranasal medication in the 4 weeks prior to Day 1, 3. Has received a previous dose of gadolinium-based contrast agent in their lifetime 4. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to screening. 5. Has a history of cardiovascular, cerebrovascular, or peripheral vascular disease, including, but not limited to, unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, bradycardia, or tachycardia. 6. Has a clinically significant history or presence of electrocardiogram findings at screening. 7. Has clinically significant laboratory abnormalities, 8. Current symptomatic seasonal allergic rhinitis (hayfever). 9. History of severe allergy or anaphylaxis to any drug, food, toxin or other exposure. 10. History of moderate or severe substance abuse within 5 years prior to screening. 11. History of alcohol abuse within 5 years prior to screening. 12. Positive test results for hepatitis B surface antigen, hepatitis B core antibodies, hepatitis C virus antibody, and human immunodeficiency virus (HIV) p24 antigen and HIV type 1 and type 2 antibodies at screening 13. Smoked any tobacco or related products within 3 months prior to dosing, 14. With the exception of oral contraceptives or hormone replacement therapy, is taking over-the-counter or prescription medications or herbal, nutritional or dietary supplements. 15. Received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) prior to dosing 16. Has donated blood or plasma within 30 days prior to screening or has had a loss of whole blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening. 17. Has experienced acute upper respiratory illness including a common cold, within 14 days prior to screening or baseline visits. 18. Unable to undergo MRI scanning due to the presence of non-removable metal implants, claustrophobia or any other contraindication 19. Other unspecified reasons that, in the opinion of the PI or Sponsor, make the participant unsuitable for enrollment.
Outcome results
None listed