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

NCT07762443 | Not Yet Recruiting Phase 1

• 1 other identifier: VC005-111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Alopecia Areata

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 (2)

VC005 Tablets Low Dose groups

EXPERIMENTAL

Drug: VC005 tablets

VC005 Tablets High Dose groups

EXPERIMENTAL

Drug: VC005 tablets

Interventions

VC005 tablets DRUG

VC005 repeat administration for 24 weeks

VC005 Tablets High Dose groups; VC005 Tablets Low Dose groups

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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 ≥ 40 kg.
• Subjects must meet the diagnostic criteria for alopecia areata (AA) at both screening and baseline visits.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

The Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jianzhong Zhang

  The Peking University People's Hospital, Beijing, Beijng

  PRINCIPAL INVESTIGATOR

• cheng zhou

  The Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaojuan lai

CONTACT

+8615358160458; lai_xiaojuan@vcarepharmatech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

CN (1)