Current partner codePEPTIDESDE
NCT07539415·Phase 1·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 1

Enrollment

72

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

DWRX5003

Microneedle patch containing Semaglutide

DRUG

DWC202502

Semagluide

DRUG

DWC202503

Semaglutide

OTHER

DWRX5003P

placebo microneedle patch

Timeline

From registration to results.

  1. First posted

    Apr 20, 2026

  2. Study start

    May 6, 2026

  3. Primary completion

    Oct 27, 2026

  4. Study completion

    Nov 17, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 16, 2026

Outcomes

What the study measures.

Primary outcomes

AUC 0-t

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

Cmax

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

Secondary outcomes

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

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

CL/F, Vd/F

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

Clearance, Volume of distribution

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)

Frel

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

Relative bioavailability compared to the active control

Eligibility

Who can take part.

Minimum age
19 Years
Maximum age
64 Years
Sex
ALL
Healthy volunteers
Yes

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 locations

1 registered sites.

South Korea. Showing up to 24 locations stored in the fast local snapshot.

Seoul National University Hospital

Seoul, South Korea

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.