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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events (AEs)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Part A: Fasting
Single ascending dose (SAD).
Intervention: NXC736 (Drug)
Part A: Fasting
Single ascending dose (SAD).
Intervention: Placebo (Drug)
Part A: Fed
Single ascending dose (SAD).
Intervention: NXC736 (Drug)
Part A: Fed
Single ascending dose (SAD).
Intervention: Placebo (Drug)
Part B: Fasting
Multiple Ascending Dose (MAD)
Intervention: NXC736 (Drug)
Part B: Fasting
Multiple Ascending Dose (MAD)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events (AEs)
Time Frame: Day 49
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Day 49
Number of Participants with Vital Sign Abnormalities
Time Frame: Day 49
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time Frame: Day 49
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Day 49
Secondary Outcomes
No secondary outcomes reported