A Phase 1 study to look at the safety of an intranasal formulation of an MRI contrast agent in healthy adults

INTERVENTION: 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. CONDITION: MRI imaging for diagnostic purposes; ; MRI imaging for diagnostic purposes Public Health ‐ Other public health SECONDARY OUTCOME: To assess the amount of gadolinium in blood after a single intranasal dose of INB‐01[Blood samples will be collected at screening (Stage 1 and Stage 2) and then prior to discharge from the clinic on Day 1 (Stage 2 at 6 hours post dose)] To assess the amount of gadolinium in urine after a single intranasal dose of INB‐01[Urine will be collected at screening (Stage 1 and Stage 2) and prior to discharge from the clinic on Day 1 (Stage 2 at 6 hours post dose)] To quantify the delivery of gadolinium in different areas of the brain following a single intranasal dose of INB‐01 by measuring the contrast levels from MRI scans[MRI scans will be conducted prior to dosing and at 30 minutes, 1 hour, 3 hours and 5 hours after dosing on Day 1] 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 inde X(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 PRIMARY OUTCOME: To evaluate the safety and tolerability of an intranasal dose of INB‐01 Intranasal Solution in healthy adult participants through the composite assessment of: treatment‐emergent adverse events assessed through regular solicitation of participants and review of physical examination data, nasal examination data collected using a nasal speculum, vital sign data including blood pressure measured using a digital blood pressure monitor, heart rate measured as beats per minute, temperature assessed using a digital thermometer and respiratory rate measured using a manual counting of breaths per minute, ECG data, clinical laboratory assessments of blood and urine: hematology (standard panel), chemistry (standard panel) and urinalysis (standard panel), nasal symptoms assessed through a questionnaire, changes in a participants ability to smell assessed through a smell identification test, and tolerability of the intranasal dose assessed from a visual analogue scale of tolerability and a questionnaire on nasal symptoms that was designed for use in the study.[Treatment emergent adverse events and serious adverse events will be collected from the start of dosing through the end of study visit on Day 8.; Physical and nasal examination will be conducted at screening and prior to discharge from the clinic on Day 1. (4 hours post dose in Stage 1 and 6 hours post dose in Stage 2); Vital signs will be measured at screening and on Day 1 prior to dosing and then post dose and prior to discharge from the clinic (30 minutes, 2 hours and 4 hours post dose in Stage 1 and 2 hours, 4 hours and 6 hours post dose in Stage 2).; ECG data will be collected and on Day 1 prior to dosing and then prior to discharge from the clinic (4 hours post dose in Stage 1 and 6 hours post dose in Stage 2).; Clinical laboratory assessment of blood and urine will be collected at screening and prior to discharge from the clinic on Day 1 (4 hours post dose in Stage 1 and 6 hours post dose in Stage 2); The nasal symptom questionnaire will be completed at screening, on Day 1 prior to dosing and then post dose and prior to discharge from the clinic (2 hours and 4 hours post dose in Stage 1 and 2 hours and 6 hours post dose in Stage 2).; The smell identification test will be conducted at screening and prior to discharge from the clinic on Day 1.(4 hours post dose in Stage 1 and 6 hours post dose in Stage 2); The tolerability questionnaire will be completed after dosing and prior to discharge from the clinic on Day 1. (30 minutes, 2 hours and 4 hours post dose in Stage 1 and 15 minutes, 2 hours, 4 hours and 6 hours post dose in Stage 2).]