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This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KN-002 for SAD (Part 1) | Experimental | Up to 6 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002 |
|
| Placebo for SAD (Part 1) | Placebo Comparator | Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo |
|
| KN-002 for MAD (Part 2) | Experimental | Up to 4 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002 |
|
| Placebo for MAD (Part 2) | Experimental | Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo |
|
| KN-002 for Part 3 | Experimental | Single cohort with up to 18 of 24 subjects randomised to active treatment |
|
| Placebo for Part 3 | Experimental | Single cohort with up to 6 of 24 subjects randomised to placebo treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN-002 | Drug | KN-002 dry powder inhaler |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events | To assess the safety and tolerability of KN-002 via the assessment of the number, severity and type of treatment emergent adverse events post single and repeat dose administration to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD | Day 1 to 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC) | KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD: | Day 1 to 17 |
| Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Singh | Medicines Evaluation Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
Kinaset Therapeutics Inc. will not disclose individual subject de-identified study data
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|
| KN-002 for Part 4 | Experimental | Single cohort with up to 18 of 24 subjects randomised to active treatment |
|
| Placebo for Part 4 | Experimental | Single cohort with up to 6 of 24 subjects randomised to placebo treatment |
|
KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD: |
| Day 1 to 17 |
| Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels | Change of fractional exhaled nitric oxide (FeNO) levels after repeated dosing to patients with mild asthma, moderate to severe asthma and COPD | Day 1 to 17 |