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

Phase 3

Completed

• Conditions: Parenteral Nutrition
• Interventions: Drug: IN-C006 Peri inj.; Drug: RPN301

• Registration Number: NCT05337228
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Study Start: 2022-08-09
• Status Verified: 2023-02
• Primary Completion: 2023-02-10
• Study Completion: 2023-02-24
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IN-C006 Peri inj.	IN-C006 Peri inj.	IN-C006 Peri inj. 1904 mL
RPN301	RPN301	RPN301 2020 mL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in vital sign (Body temperature)	Day 1 to Day 4	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(℃)
Change in nutritional management parameters(Nitrogen balance)	Day 1 to Day 4	Nitrogen balance(Nitrogen intake-Nitrogen out)
Change in nutritional management parameters(Prealbumin)	Day 1 to Day 4	Prealbumin(mg/L)
Change in nutritional management parameters(Albumin)	Day 1 to Day 4	Albumin(g/dL)
Change in nutritional management parameters(Transferrin)	Day 1 to Day 4	Transferrin(mg/dL)
Change in inflammation parameters(hs-CRP)	Day 1 to Day 4	hs-CRP(mg/L)
Change in inflammation parameters(TNF-α)	Day 1 to Day 4	TNF-α(pg/mL)
Change in inflammation parameters(IL-6)	Day 1 to Day 4	IL-6(pg/mL)
Change in fatty acid profile	Day 1 to Day 4	LA(ug/mL), AA(ug/mL), EPA(ug/mL), DHA(ug/mL)
Incidence of Adverse event	Day 1 to Day 4	Rate of adverse events as assessed by CTCAE v5.0 and investigator's evaluation
Change in laboratory parameters (Hematology)	Day 1 to Day 4	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
Change in laboratory parameters (Blood chemistry)	Day 1 to Day 4	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
Change in laboratory parameters (Blood coagulation test)	Day 1 to Day 4	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
Change in laboratory parameters (Urinalysis)	Day 1 to Day 4	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
Change in vital sign (Respiratory rate)	Day 1 to Day 4	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)
Change in vital sign (Blood pressure)	Day 1 to Day 4	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)
Change in vital sign (Pulse rate)	Day 1 to Day 4	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)
Normal and abnormal change in physical examination (Frequency)	Day 1 to Day 4	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
Normal and abnormal change in physical examination (Ratio)	Day 1 to Day 4	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of