Alopecia AreataPhase 1NCT07762443
A Phase I Study of VC005 Tablets in Adolescent Subjects With Severe Alopecia Areata
A Phase 1 study testing VC005 tablets in people with Alopecia Areata, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- VC005 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2026to 30 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Peking University People's Hospital
Beijing, Beijing Municipality
Jianzhong Zhang, 010-88325471, rmzjz@126.com
About this study
Official title: A Phase I Study to Evaluate the Pharmacokinetics, Safety, and Preliminary Efficacy 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).
- Conditions
- Alopecia Areata
- Being tested
- VC005 tablets
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VC005 tabletsDrug
VC005 repeat administration for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| VC005 Tablets Low Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
| VC005 Tablets High Dose groups | Experimental | Not described Receives: Drug: VC005 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Measured: Day1，Day28
Peak Plasma Concentration (Cmax）
Measured: Day1，Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start22 Sep 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Principal investigator, The Peking University People's Hospital, Beijing, Beijngcheng zhou, Principal investigator, The Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762443
- Sponsor's protocol ID
- VC005-111
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No