Clinical Trial to Evaluate the Safety and Efficacy of IN-C006 Inj. Compared With RCN301

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 inj. and RCN301 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 inj. or RCN301)

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 Inj. Compared With RCN301 in Postoperative Patients Requiring Central Parenteral Nutrition

Conditions
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Parenteral Nutrition

Intervention / Treatment
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* Drug: IN-C006 inj.
* Drug: RCN301


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 central 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 inj.<br>IN-C006 inj. 1970 mL | Drug: IN-C006 inj.<br>* IN-C006 will be injected continuously for 3 days.<br>* Other names: IN-C006 inj;|
| Active Comparator: RCN301<br>RCN301 1820 mL | Drug: RCN301<br>* RCN301 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 intake-Nitrogen out), Prealbumin(mg/L), Albumin(g/dL), Transferrin(mg/dL) | Day 1 to Day 4 | 
| Change in inflammation parameters | hs-CRP(mg/L), TNF-α(pg/mL), 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, Blood chemistry, Blood coagulation test, Urinalysis | Day 1 to Day 4 | 
| Change in vital sign | Blood pressure(mmHg), pulse rate(rate), body temperature(℃) and respiratory rate(rate) | Day 1 to Day 4 | 
| Normal and abnormal change in physical examination | 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 |