A Phase I Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of VC005 Tablets in Adolescent Subjects With Severe Alopecia Areata
| Registry | NCT07762443 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 24 (Estimated) |
| Sponsor | Jiangsu vcare pharmaceutical technology co., LTD (Industry) |
| Conditions | Alopecia Areata |
| Interventions | VC005 tablets (Drug) |
| Dates | start 2026-09-22, primary completion 2027-12-30 (estimated), completion 2027-12-30 (estimated), first posted 2026-08-13, last updated 2026-10-20 |
| Locations | 1 site in China |
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All trials for Alopecia Areata All trials of VC005 tablets
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Drug: VC005 tablets | |
| VC005 Tablets High Dose groups | Experimental | Drug: VC005 tablets |
Sex: All, ages: 12 Years to 18 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| The Peking University People's Hospital | Beijing, Beijing Municipality | China | Recruiting |