Recruiting NCT07539415

A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers

Phase I Interventional Obesity & Overweight Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: DWRX5003, DWC202502, DWC202503, DWRX5003P.
Who it may be relevant to: Registry conditions: Obesity & Overweight, Type 2 Diabetes. Basic parameters: 19 years — 64 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: South Korea
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults

Secondary outcome measures (4)

AUC 0-8h, AUC 0-168h, AUCinf [Time frame: Pre-dose (0 hour) up to 672 hours post-dose]
CL/F, Vd/F [Time frame: Pre-dose (0 hour) up to 672 hours post-dose]
Tmax, t½ [Time frame: Pre-dose (0 hour) up to 672 hours post-dose]
Frel [Time frame: Pre-dose (0 hour) up to 672 hours post-dose]

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

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)
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

South Korea · 1 center

NCT: NCT07539415 · DW_DWRX5003101