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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05079425
• Other study ID #: NXC736-001
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: February 2023
• Source: NEXTGEN Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• NXC736
Oral administration
• Placebo
Oral administration

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
NEXTGEN Bioscience

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)		Day 49
Primary	Number of Participants with Serious Adverse Events (SAEs)		Day 49
Primary	Number of Participants with Vital Sign Abnormalities		Day 49
Primary	Number of Participants with Electrocardiogram (ECG) Abnormalities		Day 49
Primary	Number of Participants with Clinical Laboratory Abnormalities		Day 49