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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07762443

Enrollment

Registered

2026-08-13

Start date

2026-09-30

Completion date

2027-12-30

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata

Brief summary

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).

Interventions

DRUGVC005 tablets

VC005 repeat administration for 24 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Contacts

CONTACTxiaojuan lai

lai_xiaojuan@vcarepharmatech.com+8615358160458

PRINCIPAL_INVESTIGATORJianzhong Zhang

The Peking University People's Hospital, Beijing, Beijng

PRINCIPAL_INVESTIGATORcheng zhou

The Peking University People's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026