Safety-first test of DWRX5003 and related compounds in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial enrolling healthy adults aged 19 to 65 to assess the safety of DWRX5003 and compare its relative bioavailability to DWC202502 and DWC202503. The study will involve administering the investigational products, monitoring for adverse effects, and measuring laboratory and physiological responses to characterize safety and pharmacokinetics. Eligibility requires no significant medical history or conditions, with standard screenings including labs, vital signs, exams, and ECG. Lead sponsor is Daewoong Pharmaceutical Co. Ltd., with Seoul National University Hospital as the study site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 and ≤ 65 years at screening
2. 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
3. Subjects with no congenital disease or chronic disease requiring treatment as well as no pathologic symptoms or findings based on medical examination
4. 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
5. 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:

1. Subjects with past or current medical history of clinically significant hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematologic, oncologic, genitourinary, cardiovascular, digestive, and musculoskeletal diseases:
2. Females who are pregnant (serum-HCG positive) or breast-feeding
3. 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)
4. 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
5. Subjects with a history of acute or chronic pancreatitis
6. Subjects with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
7. Subjects who are deemed ineligible for participation in the study by the investigator for reasons other than the above inclusion/exclusion criteria etc.

Where it's running

• Seoul National University Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: YeaRa Kwak
• Email: yeara.kwak@daewoong.co.kr
• Phone: +8225508317

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.