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

Phase 3

Completed

• Conditions: Parenteral Nutrition
• Interventions: Drug: IN-C006 inj.; Drug: RCN301

• Registration Number: NCT05299099
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

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)

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Study Start: 2022-05-04
• Primary Completion: 2022-12-09
• Study Completion: 2022-12-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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/㎡

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IN-C006 inj.	IN-C006 inj.	IN-C006 inj. 1970 mL
RCN301	RCN301	RCN301 1820 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 inflammation parameters	Day 1 to Day 4	hs-CRP(mg/L), TNF-α(pg/mL), 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
Normal and abnormal change in physical examination	Day 1 to Day 4	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
Change in nutritional management parameters	Day 1 to Day 4	Nitrogen balance(Nitrogen intake-Nitrogen out), Prealbumin(mg/L), Albumin(g/dL), Transferrin(mg/dL)
Change in laboratory parameters	Day 1 to Day 4	Hematology, Blood chemistry, Blood coagulation test, Urinalysis
Change in vital sign	Day 1 to Day 4	Blood pressure(mmHg), pulse rate(rate), body temperature(℃) and respiratory rate(rate)

Trial Locations

Locations (1)

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