NCT07329101

Brief Summary

This is a single arm, and open-label phase I study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2026

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

December 29, 2025

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC)

    Day1,Day28

  • Peak Plasma Concentration (Cmax)

    Day1,Day28

Study Arms (1)

VC005

EXPERIMENTAL
Drug: VC005

Interventions

VC005DRUG

VC005 with Local topical application

VC005

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • When giving informed consent, the age range is 12-18 years old (including 12 years old), with no gender restrictions;
  • The subjects and their guardians voluntarily sign an informed consent form (dated), indicating that the subjects have been informed of all relevant parts of the study;
  • All women and all men with the potential to conceive must be willing to use at least one highly effective method of contraception from the time of signing the informed consent form until 3 months after the last administration of the investigational drug

You may not qualify if:

  • Subjects suspected to be allergic to VC005 gel or to excipients in VC005 gel, or with ≥ 2 kinds of drug allergy history in the past;
  • The researchers believe that there may be skin injuries or abnormalities in the subjects that could affect the evaluation of the administration site of the investigational drug;
  • The researchers believe that the subjects have clinically relevant skin diseases that are contraindicated in the study or affect the evaluation of the administration site, including but not limited to psoriasis, acne, dysplastic nevi, and skin cancer;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Liming Wu

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 9, 2026

Study Start

November 11, 2025

Primary Completion

February 6, 2026

Study Completion

February 28, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations