A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety Between Administration of BR2021 and BR2021-1

NCT06867497 | Recruiting Phase 1

• 1 other identifier: BR-ABX-CT-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical study is to compare and evaluate the pharmacokinetic characteristics and the safety between administration of BR2021 and BR2021-1 in patients with metastatic adenocarcinoma of the pancreas

Conditions

Metastatic Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (2)

• AUCt

  Area under the Plasma Concentration-Time Curve from 0 to time t

  0~72 hours after administration

• Cmax

  Maximum Concentration of Drug in Plasma

  0~72 hours after administration

Study Arms (2)

Test drug

EXPERIMENTAL

Drug: BR2021

Reference drug

ACTIVE COMPARATOR

Drug: BR2021-1

Interventions

BR2021 DRUG

intravenous administration for 30 minutes

Test drug

BR2021-1 DRUG

intravenous administration for 30 minutes

Reference drug

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those with histologically or cytologically proven metastatic adenocarcinoma of the pancreas
• Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically recognized methods of contraception (contraceptives administration \& transplantation or intrauterine device(IUD), sterilization(vasectomy, tubal ligation, etc.), barrier methods (spermicide \& male condom, combined use of contraceptive diaphragm, sponge or cervical cap)) from the date of the first administration of the investigational products to at least 6 months after the last administration date and disagree to provide their sperm or ovum.
• Those who spontaneously decide to participate and sign written consent to comply with the subject's precautions after listening to and fully understanding detailed explanation of this clinical trial

You may not qualify if:

• In the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
• Those who have to administer this study's contraindicated drugs with the investigational product from 2 weeks before the participation until end of this study
• Those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug from 48 hours before the first administration date to post study visit(PSV)
• Those who can't discontinue other drugs except the investigational product of this study that may affect the metabolism and excretion of the drug for the entire study period (However, if necessary, such as treatment of adverse event, it can be administrated according to investigator's judgment)
• Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 4 weeks before the first administration date (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products) or those whose last administration date of their investigational products of other clinical trials doesn't elapse five times the half-life of their investigational products based on the first administration date of investigational product of this study

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (2)

Asan Medical Center

Seoul, South Korea

RECRUITING

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Central Study Contacts

Shin-young Oh

CONTACT

+82-2-708-8000; syoh@boryung.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: February 24, 2025
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)