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

NCT07539415 | Not Yet Recruiting Phase 1

• 1 other identifier: DW_DWRX5003101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity & Overweight; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• AUC 0-8h, AUC 0-168h, AUCinf

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

• CL/F, Vd/F

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

• Tmax, t½

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

• Frel

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

Other Outcomes (6)

• 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

Study Arms (4)

DWRX5003

EXPERIMENTAL

DWRX5003 3 doses

Drug: DWRX5003

DWC202502

ACTIVE COMPARATOR

Drug: DWC202502

DWC202503

ACTIVE COMPARATOR

Drug: DWC202503

DWRX5003P

PLACEBO COMPARATOR

Other: DWRX5003P

Interventions

DWRX5003 DRUG

Microneedle patch containing Semaglutide

DWRX5003

DWC202502 DRUG

Semagluide

DWC202502

DWC202503 DRUG

Semaglutide

DWC202503

DWRX5003P OTHER

placebo microneedle patch

DWRX5003P

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

JeongHwa Kim

CONTACT

+8225508317; jeonghwa.kim@daewoong.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study employs a partial double-blind design.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: April 20, 2026
• Study Start: March 30, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)