Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects

A Two-Part Single Center, Randomized, Sequential, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTP-543 in Healthy Volunteers

Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.

This two-part study will assess, in healthy volunteers, under fasted conditions, and in a sequential manner, the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses of CTP-543.

Inclusion Criteria:

• Healthy adult males and females between 18 and 50 years of age, inclusive
• Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive

Exclusion Criteria:

• History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
• PR interval > 220 msec or QRS duration > 120 msec or QTcF interval > 450 msec obtained at screening visit or prior to the first dose of study drug
• History of herpes zoster
• Hemoglobin, white blood cell, or platelet levels below the lower reference limit at screening or prior to the first dose of study drug
• Liver function tests greater than the upper limit of normal
• Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
• Urinalysis positive for protein or glucose
• A positive screen for alcohol, drugs of abuse, or tobacco use
• Donation of blood, plasma or other blood products prior to screening
• A positive tuberculosis test