Clinical trial NCT05079425: A First-in-Human Study to Assess Single and Multiple Doses of NXC736 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NEXTGEN Bioscience
Sponsor class: INDUSTRY
First posted: 2021-10-15
Enrollment: 72
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Day 49
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Day 49
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Day 49
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Day 49
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Day 49
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine and Hospital
name: Seungwhan Lee
role: PRINCIPAL_INVESTIGATOR
References: