Not Yet 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 2026-03-30

Plain-language summary

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

Age range19 Years – 64 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

AUC 0-t

Timeframe: Pre-dose (0 hour) up to 672 hours post-dose

Cmax

Timeframe: Pre-dose (0 hour) up to 672 hours post-dose

NCT IDNCT07539415

SponsorDaewoong Pharmaceutical Co. LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-30

JeongHwa Kim

Who can participate

Age range19 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.