A multicenter clinical study to evaluate the safety, PK characteristics, immunogenicity characteristics, and PD characteristics of IBI3013 in healthy trial participants and active non-segmental vitiligo trial participants and severe alopecia areata trial participants. The study is divided into 2 parts, with Part 1 involving healthy trial participants lasting up to 24 weeks, and Part 2 involving active non-segmental vitiligo trial participants and severe alopecia areata trial participants lasting up to 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
placebo
Baricitinib tablets
Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGPart 1: Number of participants with at least one treatment-emergent adverse event
Time frame: up to 24 weeks
Part 1: Number of participants with at least one Serious treatment-emergent adverse event
Time frame: up to 24 weeks
Part 2: Number of participants with at least one treatment-emergent adverse event
Time frame: up to 48 weeks
Part 2: Number of participants with at least one Serious treatment-emergent adverse event
Time frame: up to 48 weeks
Part 1: Cmax following a single dose of IBI3013.
Time frame: up to 24 weeks
Part 1: Tmax following a single dose of IBI3013.
Time frame: up to 24 weeks
Part 1: AUC following a single dose of IBI3013.
Time frame: up to 24 weeks
Part 1: Cmin following a single dose of IBI3013.
Time frame: up to 24 weeks
Part 1: CL/F or CL following a single dose of IBI3013.
Time frame: up to 24 weeks
Part 1: Vd/F or Vd following a single dose of IBI3013.
Time frame: up to 24 weeks
Part 1: T1/2 following a single dose of IBI3013.
Time frame: up to 24 weeks
Part 1: Positive rate of anti-drug antibody following a single dose of IBI3013.
Time frame: up to Day85
Part 2: Cmax following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: Tmax following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: AUC following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: Cmin following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: CL/F following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: Vd/F following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: T1/2 following multiple doses of IBI3013.
Time frame: up to 48 weeks
Part 2: Positive rate of anti-drug antibody following multiple doses of IBI3013.
Time frame: up to 28 weeks
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