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

HK inno.N Corporation59 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Parenteral Nutrition

Interventions

IN-C006 Peri inj.DRUG

IN-C006 peri inj. will be injected continuously for 3 days.

RPN301DRUG

RPN301 will be injected continuously for 3 days.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Adverse drug reaction rate

Rate of treatment-related adverse events as assessed by CTCAE v5.0 and investigator's evaluation

Time frame: Day 1 to Day 4

Secondary Outcomes

Change in nutritional management parameters(Nitrogen balance)

Nitrogen balance(Nitrogen intake-Nitrogen out)

Time frame: Day 1 to Day 4

Change in nutritional management parameters(Prealbumin)

Prealbumin(mg/L)

Time frame: Day 1 to Day 4

Change in nutritional management parameters(Albumin)

Albumin(g/dL)

Time frame: Day 1 to Day 4

Change in nutritional management parameters(Transferrin)

Transferrin(mg/dL)

Time frame: Day 1 to Day 4

Change in inflammation parameters(hs-CRP)

hs-CRP(mg/L)

Time frame: Day 1 to Day 4

Change in inflammation parameters(TNF-α)

TNF-α(pg/mL)

Time frame: Day 1 to Day 4

Change in inflammation parameters(IL-6)

IL-6(pg/mL)

Time frame: Day 1 to Day 4

Change in fatty acid profile

LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Day 1 to Day 4

Incidence of Adverse event

Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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(℃)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: Day 1 to Day 4