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NCT Number: NCT07762443

A Phase I Study 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).

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Peking University People's Hospital

Beijing, Beijing Municipality, China

Location contact

Jianzhong Zhang

CONTACT

[email protected]

010-88325471

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VC005 tablets

Drug

VC005 repeat administration for 24 weeks

Primary outcomes

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

    Time frame: Day1,Day28

  2. Peak Plasma Concentration (Cmax)

    Time frame: Day1,Day28

Study contacts

Contact information is provided by the study sponsor or research team.

xiaojuan lai

CONTACT

[email protected]

+8615358160458

Sponsors and collaborators

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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