Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301

A Randomized, Open-label, Multi-center Phase III Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Peri Inj. Compared With RPN301 in Postoperative Patients Requiring Peripheral Parenteral Nutrition

This study is designed to evaluate the safety and efficacy of IN-C006 Peri inj. and RPN301 in postoperative patients requiring central parenteral nutrition.

Study Overview

• Status: Completed
• Conditions: Parenteral Nutrition
• Intervention / Treatment: Drug: IN-C006 Peri inj.; Drug: RPN301

Detailed Description

This study is a randomized, open-label, phase 3 design. The subject will be assigned to one of the two treatment groups (IN-C006 Peri inj. or RPN301)

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 3

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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age over 19 at the time of obtaining the informed consent form
• Requiring over 3 days of parenteral nutrition via a peripheral vein after an operation
• BMI 16 ~ 30 kg/㎡

Exclusion Criteria:

• Has received parenteral nutrition within 7 days of screening
• Severe dyslipidemia
• Uncontrolled diabetes
• Clinically significant liver disease
• Clinically significant kidney disease

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IN-C006 Peri inj.; IN-C006 Peri inj. 1904 mL	Drug: IN-C006 Peri inj.; IN-C006 peri inj. will be injected continuously for 3 days.
Active Comparator: RPN301; RPN301 2020 mL	Drug: RPN301; RPN301 will be injected continuously for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug reaction rate	Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation	Day 1 to Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatty acid profile	LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL)	Day 1 to Day 4
Incidence of Adverse event	Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation	Day 1 to Day 4
Change in nutritional management parameters(Nitrogen balance)	Nitrogen balance(Nitrogen intake-Nitrogen out)	Day 1 to Day 4
Change in nutritional management parameters(Prealbumin)	Prealbumin(mg/L)	Day 1 to Day 4
Change in nutritional management parameters(Albumin)	Albumin(g/dL)	Day 1 to Day 4
Change in nutritional management parameters(Transferrin)	Transferrin(mg/dL)	Day 1 to Day 4
Change in inflammation parameters(hs-CRP)	hs-CRP(mg/L)	Day 1 to Day 4
Change in inflammation parameters(TNF-α)	TNF-α(pg/mL)	Day 1 to Day 4
Change in inflammation parameters(IL-6)	IL-6(pg/mL)	Day 1 to Day 4
Change in laboratory parameters (Hematology)	Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group - Hematology	Day 1 to Day 4
Change in laboratory parameters (Blood chemistry)	Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group - Blood chemistry	Day 1 to Day 4
Change in laboratory parameters (Blood coagulation test)	Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group - Blood coagulation test	Day 1 to Day 4
Change in laboratory parameters (Urinalysis)	Difference in the proportion of subjects whose test results changed from normal to abnormal between the IN-C006 Peri group and the RPN301 group - Urinalysis	Day 1 to Day 4
Change in vital sign (Blood pressure)	Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) - Systolic blood pressure(mmHg), Diastolic blood pressure(mmHg)	Day 1 to Day 4
Change in vital sign (Pulse rate)	Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) - Pulse rate(rate)	Day 1 to Day 4
Change in vital sign (Body temperature)	Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) - Body temperature(℃)	Day 1 to Day 4
Change in vital sign (Respiratory rate)	Changes between the IN-C006 Peri group and the RPN301 group (mean difference at the last visit compared to the Baseline (Day 1)) - Respiratory rate(rate)	Day 1 to Day 4
Normal and abnormal change in physical examination (Frequency)	Frequency of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products - General Appearance, HEENT (Head, Eyes, Ears, Nose, Throat), Skin (including hair, nails), Respiratory, Cardiovascular, Chest/Lungs/Breast, Abdominal/Gastrointestinal, Musculoskeletal, Extremities/Joint, Neurological/Psychological, Lymph nodes, Rectal/Pelvic/Genitalia, Other	Day 1 to Day 4
Normal and abnormal change in physical examination (Ratio)	Ratio of subjects who were normal/clinically insignificant abnormalities before administration of investigational products to clinically significant abnormalities at least once after administration of investigational products - General Appearance, HEENT (Head, Eyes, Ears, Nose, Throat), Skin (including hair, nails), Respiratory, Cardiovascular, Chest/Lungs/Breast, Abdominal/Gastrointestinal, Musculoskeletal, Extremities/Joint, Neurological/Psychological, Lymph nodes, Rectal/Pelvic/Genitalia, Other	Day 1 to Day 4

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Study Chair: Do Joong PARK, Seoul National Univerity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): February 24, 2023

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IN_PPN_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