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This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part 1) followed by a multiple ascending dose (MAD) part (Part 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT-301B | Active Comparator | AT-301B consists of edetate disodium, glyceryl monooleate, polysorbate 80, benzalkonium chloride, microcrystalline cellulose and sodium carboxymethylcellulose (vivapur), trisodium citrate dihydrate, and purified water (HCl to adjust pH to 5.0) |
|
| AT-301A | Placebo Comparator | AT-301A consists of sodium chloride, benzalkonium chloride and purified water (NaOH/HCl to adjust pH to 5.0) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-301B | Drug | Nasal Spray |
| |
| AT-301A |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac, pulmonary and hemodynamic parameters using 12-lead ECG | incidence of abnormal ECG Change from baseline in clinical laboratory parameters
| from baseline through study completion, an average of 40 days |
| auscultation | incidence of abnormal sounds Change from baseline in clinical laboratory parameters
| from baseline through study completion, an average of 40 days |
| determination of oxygen saturation levels | Incidence of abnormal oxygen saturation Change from baseline in clinical laboratory parameters
| from baseline through study completion, an average of 40 days |
| haematology, coagulation and serum chemistry | incidence of abnormal ranges Change from baseline in clinical laboratory parameters
| from baseline through study completion, an average of 40 days |
| urinalysis | incidence of abnormal measures Change from baseline in clinical laboratory parameters
|
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Spray Attributes Questionnaire score | based on a scale of 0 to 6, for each immediate attribute assessed; 0 equals none, 3 equals severe for each question; lower scores have better outcome | from baseline through study completion, an average of 40 days |
| Incidence and severity of AE (bronchospasms) |
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Inclusion Criteria:
Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects 2. Adult males and females, 18 to 64 years of age (inclusive) at the screening visit 3. Are non-smokers (including tobacco, e-cigarettes and marijuana) for a minimum of 1 month prior to the screening visit. Non-smokers with a significant history of smoking (> 5 pack years) are not eligible 4. Have a physically normal nasal structure (minor septum deviation allowable) 5. Body mass index (BMI) (calculated) within the range of 18 to 30 kg/m2 inclusive at the screening visit and prior to dosing on Day 1 6. Medically healthy without clinically significant abnormalities in the opinion of the investigator at the screening visit and prior to dosing on Day 1, including:
a. Be of non-child-bearing potential i.e., have follicle-stimulating hormone levels >40 IU/L at screening and be surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the Screening visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or b. If of childbearing potential, must have a negative pregnancy test at Screening (blood test) and before the first study drug administration (pre-dose Day 1 urine test). They must agree not to attempt to become pregnant, must not donate ova, and must agree to use a highly effective contraceptive method in addition to having their male partner use a condom (if not surgically sterilised) for penile-vaginal intercourse from signing consent until at least 30 days after the last dose of study therapy (Appendix 3) 9. Male volunteers, if not surgically sterilised, must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use a condom in addition to having the female partner use a highly effective contraceptive method (Appendix 3) from signing the consent form until at least 90 days after the last dose of study therapy (Note: male volunteers are not required to use contraception with a partner of the same sex) 10. Have suitable venous access for blood sampling 11. Willing and able to comply with the requirements of the study protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ben Canny | Bellberry Limited HREC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | South Australia | 5000 | Australia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2026 |
8 participants per cohort (randomised AT-301A/Placebo : AT-301B, 2:6). Part 1: (SAD) Participants will receive: Cohort 1 - AT- 301A/Placebo or AT-301B 0.1mL per nostril (0.2mL total); or, Cohort 2 - AT-301A/Placebo or AT-301B 0.2mL per nostril (0.4mL total).
Part 2: (MAD) Cohort 3 - AT-301A/Placebo or AT-301B 0.1mL per nostril (0.2mL total), three times/day for 14 days; or, Cohort 4 - AT- 301A/Placebo or AT-301B) 0.2mL per nostril (0.4mL total), three times/day for 14 days.
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| Drug |
Nasal Spray |
|
|
| from baseline through study completion, an average of 40 days |
AE monitoring |
| from baseline through study completion, an average of 40 days |