A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjects

NCT07027982 | Completed Phase 1

• 1 other identifier: DA5217_UGIB_I
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the pharmacokinetics and safety of Diluted and Undiluted Intravenous DA-5217 in healthy adult subjects.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• AUClast

  Area under the plasma concentration-time curve from time zero to time the last quantifiable time

  0~24hours

Study Arms (2)

Sequence 1

EXPERIMENTAL

Drug: Diluted Intravenous DA-5217; Drug: Undiluted Intravenous DA-5217

Sequence 2

EXPERIMENTAL

Drug: Diluted Intravenous DA-5217; Drug: Undiluted Intravenous DA-5217

Interventions

Diluted Intravenous DA-5217 DRUG

once a day

Sequence 1; Sequence 2

Undiluted Intravenous DA-5217 DRUG

once a day

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or female, 19 years to 45 years
• Weighing 50 kg or more, with a body mass index (BMI) of 18.5 kg/m2 to 29.9kg/m2
• The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate and complied with the precautions.

You may not qualify if:

• The subjects with existing or previous conditions that may influence the pharmacokinetics of drugs
• The subjects hypersensitive to any of the Investigational Product components or other drug components
• The subjects with clinically significant active chronic conditions
• The subjects with a positive urine drug test result or a history of drug abuse or dependence.
• The subjects who are pregnant or lactating

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13605, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: July 16, 2025
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

KR (1)