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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: NXC736

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part A: Fasting; Single ascending dose (SAD).	Drug: Placebo; Oral administration; Drug: NXC736; Oral administration
EXPERIMENTAL: Part A: Fed; Single ascending dose (SAD).	Drug: Placebo; Oral administration; Drug: NXC736; Oral administration
EXPERIMENTAL: Part B: Fasting; Multiple Ascending Dose (MAD)	Drug: Placebo; Oral administration; Drug: NXC736; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NEXTGEN Bioscience
• Investigators: Principal Investigator: Seungwhan Lee, Seoul National University College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ACTUAL): November 1, 2022
• Study Completion (ACTUAL): November 1, 2022

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (ACTUAL): October 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NXC736-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No