A First-in-Human Study to Assess Single and Multiple Doses of NXC736 in Healthy Participants

Inclusion criteria

• Healthy adult males aged between 19 and 55 at screening
• Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 30.0
• Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
• Signed informed consent form

Exclusion criteria

• Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
• Those who have gastrointestinal diseases or past history of gastrointestinal diseases that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
• A person who shows any of the following results in vital signs at the time of screening

• Systolic blood pressure below 90 mmHg or above 140 mmHg
• diastolic blood pressure less than 50 mmHg or greater than 90 mmHg
• Pulse rate less than 50 beats per minute or more than 90 beats per minute
• A person who exhibits any of the following results from a 12-lead ECG test at the time of screening:

• PR > 210 msec
• QRS complex > 120 msec
• QTcB > 450 msec
• A person who exhibits any of the following results in a clinical laboratory examination at the time of screening ;

• glomerular filtration rate (eGFR, CKD-EPI) < 60 mL/min/1.73 m2
• WBC count < 3500/μL
• Absolute neutrophil count (ANC) < 1500/μL
• AST/ALT > 1.5 X ULN
• Those who have a history of tuberculosis infection or who have confirmed positive tuberculosis infection as a result of the Quantiferon TB-Gold test and Chest X-ray performed at the screening test
• Persons with acute infectious diseases including herpes virus infection, herpes simplex, and herpes zoster

Other protocol-defined inclusion/exclusion criteria may apply.