A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect After the Oral Administration of NXC736 in Healthy Male Subjects

NXC736-001

This is a randomized, double-blind, placebo- controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NXC736 after oral administration in healthy male volunteers.

2021-09-01

2022-11-01

2022-11-01

Completed

Early phase I

72

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.

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2023-02-08