Safety, Tolerability, and Pharmacokinetic Study of CORT113176 in Healthy Participants

Inclusion criteria

• Body mass index (BMI) of 18.0 to 30.0 kg/m^2, inclusive
• Body weight ≤100 kg.
• Must agree to adhere to the requirements on contraception, exposure to sexual partners, and sperm donation as defined in the protocol
• Additional criteria apply.

Exclusion criteria

• Received any investigational drug in a clinical research study within the last 90 days
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within past 5 years.
• Regular alcohol consumption
• Positive drug, nicotine (cotinine), or alcohol screen
• Current smokers, user of e-cigarettes and nicotine replacement products and those who have used these products within the last 3 months
• Have a pregnant partner
• Clinically significant abnormal clinical chemistry, hematology (including coagulation), or urinalysis
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) results
• Positive nasopharyngeal polymerase chain reaction (PCR) test for severe acute respiratory syndrome Covid Virus-2 (SARS-CoV-2) on Day -1 or within 8 weeks prior to screening.
• Contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose
• Active renal and/or hepatic disease
• History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal (GI), neurological, or psychiatric disorder
• Abnormalities in brain and lumbar spine, or other medical or surgical conditions or clinically significant abnormal findings, for which lumbar puncture is contraindicated
• History of clinically significant back pain, back pathology and/or back injury
• History of significant active bleeding or coagulation disorder or have taken non-steroidal anti-inflammatory drugs or other drugs that affect coagulation or platelet function within 14 days prior to lumbar puncture
• Allergy to lidocaine (Xylocaine®) or its derivatives
• Any form of cancer within the 5 years (exceptions apply)
• History and/or symptoms of adrenal insufficiency
• Have a condition that could be aggravated by glucocorticoid antagonism
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months or 3 months for inhaled products
• Additional criteria apply.