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A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (Part 1) | Experimental |
| |
| Multiple Ascending Dose (Part 2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRN04894 Oral Solution | Drug | CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with treatment-emergent adverse events | Part 1 - up to Day 8; Part 2 - up to Day 20 | |
| Proportion of participants with a clinically significant safety laboratory observation | Part 1 - up to Day 8; Part 2 - up to Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of CRN04894 | Part 1 - up to Day 8; Part 2 - up to Day 20 |
| Pharmacokinetics (Cmax) | Assessment of the maximum observed plasma concentration of CRN04894 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ACTH-stimulated serum cortisol | Part 1 - Day 1; Part 2 - Day 10 | |
| Change in serum cortisol | Part 1 - up to Day 8; Part 2 - up to Day 20 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS-Miami Research Associates | Miami | Florida | 33143 | United States |
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| Placebo Oral Solution | Drug | Placebo |
|
| Part 1 - up to Day 8; Part 2 - up to Day 20 |
| Pharmacokinetics (Tmax) | Assessment of time to maximal CRN04894 concentration (Tmax) | Part 1 - up to Day 8; Part 2 - up to Day 20 |
| Pharmacokinetics (T1/2) | Assessment of elimination half-life of CRN04894 | Part 1 - up to Day 8; Part 2 - up to Day 20 |