NCT07762443Not yet recruitingPhase 1
A Phase I Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy of VC005 Tablets in Adolescent Subjects With Severe Alopecia Areata
Jiangsu vcare pharmaceutical technology co., LTD1 site in 1 country24 target enrollmentStarted: September 30, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
VC005 Tablets Low Dose groups
Experimental
Intervention: VC005 tablets (Drug)
VC005 Tablets High Dose groups
Experimental
Intervention: VC005 tablets (Drug)
Outcomes
Primary Outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Time Frame: Day1，Day28
Peak Plasma Concentration (Cmax）
Time Frame: Day1，Day28
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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