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

NCT05079425 | Completed Phase 1

• 1 other identifier: NXC736-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Part A: Fasting

EXPERIMENTAL

Single ascending dose (SAD).

Drug: NXC736; Drug: Placebo

Part A: Fed

EXPERIMENTAL

Single ascending dose (SAD).

Drug: NXC736; Drug: Placebo

Part B: Fasting

EXPERIMENTAL

Multiple Ascending Dose (MAD)

Drug: NXC736; Drug: Placebo

Interventions

NXC736 DRUG

Oral administration

Part A: Fasting; Part A: Fed; Part B: Fasting

Placebo DRUG

Oral administration

Part A: Fasting; Part A: Fed; Part B: Fasting

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NEXTGEN Bioscience: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Seungwhan Lee

  Seoul National University College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 15, 2021
• Study Start: September 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)