NCT07828639

Brief Summary

This study is a multicenter, open-label, non-randomized study designed to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of VC005 tablets in adolescent subjects with Non-Segmental Vitiligo

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
8mo left

Started Sep 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026May 2027

First Submitted

Initial submission to the registry

September 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 25, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

September 15, 2026

Last Update Submit

September 15, 2026

Conditions

Non-Segmental Vitiligo

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 Tablets

EXPERIMENTAL
Drug: VC005 tablets

Interventions

VC005 tabletsDRUG

VC005 repeat administration for up to 24 weeks

VC005 Tablets

Eligibility Criteria

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

You may qualify if:

  • The subject fully understands this study and is able to comply with the relevant trial procedures. The subject and their legal guardian voluntarily sign the informed consent form (ICF).
  • Age 12 to 18 years inclusive (including 12 years old, excluding 18 years old) at the time of signing the ICF, both genders, with body weight ≥ 30 kg.
  • Subjects with a clinical diagnosis of non-segmental vitiligo

You may not qualify if:

  • Pregnant or breastfeeding women, or subjects planning to become pregnant or breastfeed during the study period.
  • Trial participants with complete depigmentation of hair within the vitiligo area.
  • Trial participants clinically diagnosed with segmental vitiligo, mucosal non-segmental vitiligo, or other cutaneous depigmentation disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Study Officials

  • Jianzhong Zhang Zhang

    The Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

  • cheng zhou

    The Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaojuan Lai

CONTACT

15358160458lai_xiaojuan@vcarepharmatech.com

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

September 15, 2026

First Posted

September 18, 2026

Study Start

September 25, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

September 18, 2026

Record last verified: 2026-09

Locations

CN(1)