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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 64
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
YeaRa Kwak
yeara.kwak@daewoong.co.kr
+8225508317
Time Frame
Start Date: 2026-05-06
Estimated Completion Date: 2026-11-17
Participants
Target number of participants: 72
Treatments
Experimental: DWRX5003
DWRX5003 3 doses
Active_comparator: DWC202502
Active_comparator: DWC202503
Placebo_comparator: DWRX5003P
Related Therapeutic Areas
Sponsors
Leads: Daewoong Pharmaceutical Co. LTD.

This content was sourced from clinicaltrials.gov