A Phase I Study of VC005 Tablets in Adolescent Subjects With Severe Alopecia Areata

August 9, 2026 updated by: Jiangsu vcare pharmaceutical technology co., LTD

A Phase I Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of VC005 Tablets in Adolescent Subjects With Severe Alopecia Areata

This study is a multicenter, open-label, non-randomized, dose-finding Phase I study designed to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of VC005 tablets in adolescent subjects with severe alopecia areata (AA).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • The Peking University People's Hospital
        • Contact:
          • Jianzhong Zhang
          • Phone Number: 010-88325471
          • Email: rmzjz@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 ≥ 40 kg.
  • Subjects must meet the diagnostic criteria for alopecia areata (AA) at both screening and baseline visits.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding, or subjects who plan to become pregnant or breastfeed during the study period.
  • Subjects with a current diagnosis of acute diffuse alopecia areata (AA).
  • Subjects with a current diagnosis of other types of alopecia that may interfere with the evaluation of AA, including but not limited to traction alopecia, cicatricial alopecia, telogen effluvium, androgenetic alopecia, syphilitic alopecia, anagen effluvium, folliculotropic mycosis fungoides, or alopecia caused by thyroid disease, etc.
  • Subjects with other scalp diseases that may affect the assessment of AA, such as scalp psoriasis, dermatitis, tinea capitis, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VC005 Tablets Low Dose groups
Drug: VC005 tablets
VC005 repeat administration for 24 weeks
Experimental: VC005 Tablets High Dose groups
Drug: VC005 tablets
VC005 repeat administration for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Time Frame: Day1，Day28
Day1，Day28
Peak Plasma Concentration (Cmax）
Time Frame: Day1，Day28
Day1，Day28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Investigators

  • Principal Investigator: jianzhong Zhang, The Peking University People's Hospital, Beijing, Beijng
  • Principal Investigator: cheng zhou, The Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

August 9, 2026

First Submitted That Met QC Criteria

August 9, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 9, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC005-111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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