Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CRN04894 Oral Solution
* Drug: Placebo Oral Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study Male subjects must be surgically sterile or agree to use highly effective form of contraception when sexually active with a female partner of child bearing potential ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening Exclusion Criteria: Use of topical, nasal, inhaled, or oral corticosteroids. Use of any investigational drug within the past 60 days. Have a medically significant illness within 30 days prior to screening. Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study. Unstable psychological disorder ≤1 year prior to Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Ascending Dose (Part 1)<br> | Drug: CRN04894 Oral Solution<br>* CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.<br>Drug: Placebo Oral Solution<br>* Placebo<br>|
| Experimental: Multiple Ascending Dose (Part 2)<br> | Drug: CRN04894 Oral Solution<br>* CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.<br>Drug: Placebo Oral Solution<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |