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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05299099

Enrollment

Registered

2022-03-28

Start date

2022-05-04

Completion date

2022-12-15

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenteral Nutrition

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)

Interventions

DRUGIN-C006 inj.

IN-C006 will be injected continuously for 3 days.

DRUGRCN301

RCN301 will be injected continuously for 3 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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 vital sign	Day 1 to Day 4	Blood pressure(mmHg), pulse rate(rate), body temperature(℃) and respiratory rate(rate)
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 laboratory parameters	Day 1 to Day 4	Hematology, Blood chemistry, Blood coagulation test, Urinalysis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026