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

Nextgen Bioscience

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: NXC736

Study type: Interventional

Funder types: Industry

Identifiers

NCT05079425

NXC736-001

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups

Part A: Fasting

Experimental group

Description:

Single ascending dose (SAD).

Treatment:

Drug: Placebo

Drug: NXC736

Part A: Fed

Experimental group

Description:

Single ascending dose (SAD).

Treatment:

Drug: Placebo

Drug: NXC736

Part B: Fasting

Experimental group

Description:

Multiple Ascending Dose (MAD)

Treatment:

Drug: Placebo

Drug: NXC736