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

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

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.

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.