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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: NXC736
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Fasting<br>Single ascending dose (SAD). | Drug: NXC736<br>* Oral administration<br>Drug: Placebo<br>* Oral administration<br>|
| Experimental: Part A: Fed<br>Single ascending dose (SAD). | Drug: NXC736<br>* Oral administration<br>Drug: Placebo<br>* Oral administration<br>|
| Experimental: Part B: Fasting<br>Multiple Ascending Dose (MAD) | Drug: NXC736<br>* Oral administration<br>Drug: Placebo<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) |  | Day 49 | 
| Number of Participants with Serious Adverse Events (SAEs) |  | Day 49 | 
| Number of Participants with Vital Sign Abnormalities |  | Day 49 | 
| Number of Participants with Electrocardiogram (ECG) Abnormalities |  | Day 49 | 
| Number of Participants with Clinical Laboratory Abnormalities |  | Day 49 |