A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC2025… (NCT07539415) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
South Korea72 participantsStarted 2026-05-06
Plain-language summary
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
Who can participate
Age range
19 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening
. Subjects with a body weight ≥ 50.0 kg to ≤ 100.0 kg and a BMI of ≥ 20.0 kg/m2 to ≤ 29.9 kg/m2 at screening
. Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination
. Subjects who are determined to be eligible for this study based on results of laboratory tests, vital signs, physical examination, 12-lead electrocardiogram (ECG), etc. set and performed according to the nature of the IP at screening
. Subjects who voluntarily decided to participate in the study and provided written consent to follow subject compliance requirements during the study after receiving a detailed explanation on this study and fully understanding the information
Exclusion criteria
. Subjects with past or current medical history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, digestive, and musculoskeletal diseases:
. Females who are pregnant (serum-HCG positive) or breast-feeding
. Subjects with a history of hypersensitivity (e.g., anaphylaxis or angioedema) or clinically significant hypersensitivity to the active ingredient of the IP, pharmaceutical excipients, or other drugs (e.g., GLP-1 receptor agonists)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial focused on safety and how the drug is absorbed in healthy volunteers — since I have obesity or Type 2 diabetes, does that mean I might not even be eligible, and would participating carry any unique risks given my condition?
2The trial is comparing how three different formulations — DWRX5003, DWC202502, and DWC202503 — are absorbed in the body, but it's not yet testing whether the drug actually treats obesity or diabetes, so how far away is this from becoming a real treatment option for me?
3Because this is an early Phase 1 study, there's limited human safety data on these compounds — what are the most important risks or unknowns I should weigh before considering something at this stage of development?
4Are there already approved or well-established treatments for my condition that I should try first before considering an early-phase trial like this one?
5What does participation in a pharmacokinetic study like this typically involve in terms of clinic visits, blood draws, and time commitment, and is that realistic given my current health and schedule?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AUC 0-t
Timeframe: Pre-dose (0 hour) up to 672 hours post-dose
2
Cmax
Timeframe: Pre-dose (0 hour) up to 672 hours post-dose
. Subjects with a history of skin disease (e.g., burns, skin cancer, etc.) or skin transplant surgery that could affect the absorption of the investigational product
. Subjects with a history of acute or chronic pancreatitis
. Subjects with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
. Subjects who are deemed ineligible for participation in the study by the investigator for reasons other than the above inclusion/exclusion criteria etc.