A Study of VC005 Tablets in Adolescent Subjects With Non-Segmental Vitiligo

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-18
SponsorJiangsu vcare pharmaceutical technology co., LTD

About this trial

This study is a multicenter, open-label, non-randomized study designed to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of VC005 tablets in adolescent subjects with Non-Segmental Vitiligo

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 ≥ 30 kg.

Subjects with a clinical diagnosis of non-segmental vitiligo

Disqualifiers

Pregnant or breastfeeding women, or subjects planning to become pregnant or breastfeed during the study period.

Trial participants with complete depigmentation of hair within the vitiligo area.

Trial participants clinically diagnosed with segmental vitiligo, mucosal non-segmental vitiligo, or other cutaneous depigmentation disorders.

Trial design

Design model

Single group

Treatments tested in this trial

  • VC005 tablets

    Drug

    VC005 repeat administration for up to 24 weeks

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: VC005 TabletsExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: