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NCT Number: NCT07539415

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

Recruiting

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Seongyeon Hong, Pharm D.

CONTACT

[email protected]

+82-2-740-8872

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

DWRX5003

Drug

Microneedle patch containing Semaglutide

DWC202502

Drug

Semagluide

DWC202503

Drug

Semaglutide

DWRX5003P

Other

placebo microneedle patch

Primary outcomes

  1. AUC 0-t

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

  2. Cmax

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

Secondary outcomes

  1. AUC 0-8h, AUC 0-168h, AUCinf

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

  2. CL/F, Vd/F

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

    Clearance, Volume of distribution

  3. Tmax, t½

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

    Tmax (time to reach maximum plasma concentration), t½ (elimination half-life)

  4. Frel

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

    Relative bioavailability compared to the active control

Other outcomes

  1. AUEC0-5h, AUEC5-10h, iAUC0-5h, iAUC5-10h

    Time frame: Baseline (Day -1) to Day 8

  2. Emax of glucose

    Time frame: Baseline (Day -1) to Day 8

  3. AUEC0-168h, AUEC0-672h of glucose

    Time frame: Baseline (Day -1) to Day 8

  4. body weight

    Time frame: baseline (day -1 ) to day 29

  5. BMI

    Time frame: baseline (day -1 ) to day 29

  6. waist circumference

    Time frame: baseline (day -1 ) to day 29

Study contacts

Contact information is provided by the study sponsor or research team.

YeaRa Kwak

CONTACT

[email protected]

+8225508317

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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