Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 in Patients Who Require Parenteral Nutrition

A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 Versus NTCB-P in Patients Who Require Parenteral Nutrition

A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 versus NTCB-P in patients who require parenteral nutrition

Study Overview

• Status: Completed
• Conditions: Parenteral Nutrition
• Intervention / Treatment: Drug: NTCB01-1; Drug: NTCB-P

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dalseo-gu
    • Daegu, Dalseo-gu, Korea, Republic of, 42601
      • Keimyung University Dongsan Hospital
  • Dongjak-gu
    • Seoul, Dongjak-gu, Korea, Republic of, 07061
      • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital
  • Seo-gu
    • Busan, Seo-gu, Korea, Republic of, 49267
      • Kosin University Gospel Hospital
  • Seocho-Gu
    • Seoul, Seocho-Gu, Korea, Republic of, 06591
      • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seongbuk-gu
    • Seoul, Seongbuk-gu, Korea, Republic of, 02841
      • Korea University Anam Hospital
  • Suwon-si
    • Gyeonggi-do, Suwon-si, Korea, Republic of, 16499
      • Ajou University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Those who are 19 years old or older at the screening visit
• Patients are expected to require PN for more than 3 days
• Patients who voluntarily signed the consent form

Exclusion Criteria:

• Patients are expected difficult to survive more than 3 days
• Patients BMI is over 30 kg/m2
• Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
• Patients with difficult peripheral intravenous line
• Patients judged to be unsuitable for this trial by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NTCB01-1	Drug: NTCB01-1; 3 Days infusion
Active Comparator: NTCB-P	Drug: NTCB-P; 3 Days infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurance rate of adverse drug reaction	Day 1 to day 4

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Actual): March 28, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; 2-nitro-5-thiocyanobenzoic acid
• Other Study ID Numbers: NTCB01-301

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
• product manufactured in and exported from the U.S.: No