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| Name | Class |
|---|---|
| Avance Clinical Pty Ltd. | INDUSTRY |
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This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.
This is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled KIT2014 administered via nebulizer to healthy adult participants. The study will be conducted in 2 parts, Part A (single ascending dose, SAD) and Part B (multiple ascending doses, MAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Healthy volunteers - Up to 4 dose levels of KIT2014 will be evaluated in Part A. Dose levels will be investigated in sequential cohorts (A1 to A4) of 8 healthy participants per cohort (ratio 3:1 active:placebo). |
|
| Part B: Multiple Ascending Dose (MAD) | Experimental | Healthy volunteers - Up to 3 dose levels of KIT2014 will be evaluated in Part B. Dose levels will be investigated in sequential cohorts (B1 to B3) of 8 healthy participants per cohort (ratio 3:1 active:placebo). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KIT2014 | Drug | KIT2014 will be administered by inhalation with a nebuliser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) | Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) after single and multiple inhaled administration of KIT2014 in healthy male and female participants. | Up to 10 days post-dose in SAD and up to 14 days after the last dose in MAD |
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Major Inclusion Criteria:
Major Exclusion Criteria:
Other inclusion/exclusion eligibility criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo | Other | Placebo will be administered by inhalation with a nebuliser |
|
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |