NCT07539415 A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers
| NCT ID | NCT07539415 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Daewoong Pharmaceutical Co. LTD. |
| Condition | Obesity & Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2026-10-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2026-05-06 with a primary completion date of 2026-10-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07539415 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 64 Years, studying Obesity & Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07539415 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07539415 currently recruiting?
Yes, NCT07539415 is actively recruiting participants. Contact the research team at yeara.kwak@daewoong.co.kr for enrollment information.
Where is the NCT07539415 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07539415 clinical trial?
NCT07539415 is sponsored by Daewoong Pharmaceutical Co. LTD.. The trial plans to enroll 72 participants.
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