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This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9 subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (Part 1) | Experimental |
| |
| Multiple Ascending Dose (Part 2) | Experimental |
| |
| Elderly Cohort (Part 3) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRN01941 Oral Solution | Drug | Investigational drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events by severity | Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 | |
| Number of participants with serious adverse events (SAEs) | Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 | |
| Number of participants with clinically significant changes in vital signs | Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 | |
| Number of participants with ECG abnormalities | Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 | |
| Number of participants with clinical laboratory abnormalities | Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of CRN01941 | Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 |
| Pharmacokinetics (Cmax) | Assessment of the maximum observed plasma concentration of CRN01941 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Perth | Western Australia | 6009 | Australia |
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Single and multiple-dose cohorts are placebo-controlled.
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Double-blind study
| CRN01941 Oral Capsule | Drug | Investigational drug |
|
| Placebo Oral Solution | Drug | Placebo |
|
| Placebo Oral Capsule | Drug | Placebo |
|
| Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 |
| Pharmacokinetics (Tmax) | Assessment of the time to reach Cmax for CRN01941 | Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 |
| Pharmacokinetics (T1/2) | Assessment of the elimination half-life of CRN01941 | Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 |