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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NXC736; Drug: Placebo

• Registration Number: NCT05079425
• Lead Sponsor: NEXTGEN Bioscience

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-15
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-05
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A: Fasting	NXC736	Single ascending dose (SAD).
Part A: Fasting	Placebo	Single ascending dose (SAD).
Part A: Fed	NXC736	Single ascending dose (SAD).
Part A: Fed	Placebo	Single ascending dose (SAD).
Part B: Fasting	NXC736	Multiple Ascending Dose (MAD)
Part B: Fasting	Placebo	Multiple Ascending Dose (MAD)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of