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

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

Detailed Description
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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)

Official Title
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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

Conditions
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Parenteral Nutrition

Intervention / Treatment
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* Drug: IN-C006 Peri inj.
* Drug: RPN301


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 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 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 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 |