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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Obesity & Overweight
• Intervention / Treatment: Drug: DWRX5003; Drug: DWC202502; Drug: DWC202503; Other: DWRX5003P

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: JeongHwa Kim; Phone Number: +8225508317; Email: jeonghwa.kim@daewoong.co.kr

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul National University Hospital
    • Contact: Seongyeon Hong, Pharm D.; Phone Number: +82-2-740-8872; Email: syhongok@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWRX5003; DWRX5003 3 doses	Drug: DWRX5003; Microneedle patch containing Semaglutide
Active Comparator: DWC202502	Drug: DWC202502; Semagluide
Active Comparator: DWC202503	Drug: DWC202503; Semaglutide
Placebo Comparator: DWRX5003P	Other: DWRX5003P; placebo microneedle patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC 0-t	Pre-dose (0 hour) up to 672 hours post-dose
Cmax	Pre-dose (0 hour) up to 672 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC 0-8h, AUC 0-168h, AUCinf		Pre-dose (0 hour) up to 672 hours post-dose
CL/F, Vd/F	Clearance, Volume of distribution	Pre-dose (0 hour) up to 672 hours post-dose
Tmax, t½	Tmax (time to reach maximum plasma concentration), t½ (elimination half-life)	Pre-dose (0 hour) up to 672 hours post-dose
Frel	Relative bioavailability compared to the active control	Pre-dose (0 hour) up to 672 hours post-dose

Other Outcome Measures

Outcome Measure	Time Frame
AUEC0-5h, AUEC5-10h, iAUC0-5h, iAUC5-10h	Baseline (Day -1) to Day 8
Emax of glucose	Baseline (Day -1) to Day 8
AUEC0-168h, AUEC0-672h of glucose	Baseline (Day -1) to Day 8
body weight	baseline (day -1 ) to day 29
BMI	baseline (day -1 ) to day 29
waist circumference	baseline (day -1 ) to day 29

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DW_DWRX5003101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No