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

NCT ID: NCT05079425

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-11-01

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Part A: Fasting

Single ascending dose (SAD).

Group Type: EXPERIMENTAL

NXC736

Intervention Type: DRUG

Oral administration

Placebo

Intervention Type: DRUG

Oral administration

Part A: Fed

Single ascending dose (SAD).

Group Type: EXPERIMENTAL

NXC736

Intervention Type: DRUG

Oral administration

Placebo

Intervention Type: DRUG

Oral administration

Part B: Fasting

Multiple Ascending Dose (MAD)

Group Type: EXPERIMENTAL

NXC736

Intervention Type: DRUG

Oral administration

Placebo

Intervention Type: DRUG

Oral administration

Interventions

NXC736

Oral administration

Intervention Type: DRUG

Placebo

Oral administration

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

NEXTGEN Bioscience

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seungwhan Lee

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine and Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

NXC736-001

Identifier Type: -

Identifier Source: org_study_id