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This is a randomized, double-blind, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SKB575. This study consists of two parts. Phase Ia is a single ascending dose study in healthy subjects and Phase Ib is a proof-of-concept study in patients with moderate to severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| A2 | Experimental |
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| A3 | Experimental |
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| A4 | Experimental |
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| A5 | Experimental |
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| B1 | Experimental |
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| B2 | Experimental |
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| B3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKB575 Injection/SKB575 Placebo | Drug | Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) /TEAEs | Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs) | From Baseline to Day 225 |
| Proportion of participants achieving EASI-75 at Week 16 | EASI 75 is defined by reduction of EASI score by ≥75% from baseline | From Baseline throughout the study, up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) assessment: Cmax | Maximum plasma concentration | From baseline to Day 225 |
| Pharmacokinetic (PK) assessment: Tmax | Time to reach Cmax |
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Inclusion Criteria:
Phase Ia healthy participants must meet all of the following inclusion criteria to be enrolled:
Phase Ib participants with moderate to severe AD must meet all of the following inclusion criteria to be enrolled:
The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form.
Age at the time of signing the informed consent form is 18-70 years (inclusive), any gender.
Participant weight must be ≥ 45.0 kg.
At screening, the diagnosis of AD meets the American Dermatology Consensus Criteria (2014) (see Appendix 4) and disease duration is ≥ 1 year; and at both screening and randomization, all of the following conditions are satisfied:
Prior to screening, the participant has received at least 4 weeks of potent or 2 weeks of super potent topical corticosteroids (or systemic corticosteroids), or topical calcineurin inhibitor.
Exclusion Criteria:
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Li, PhD | Contact | 86-028-67255165 | lixin@kelun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | 200040 | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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|
| From baseline to Day 225 |
| Pharmacokinetic (PK) assessment: AUClast | Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration | From baseline to Day 225 |
| Presence of Anti-SKB575 Antibodies (ADA) | Positive rate of participant with SKB575 antibodies | From baseline to Day 225 |
| Pharmacodynamic (PD) Characteristics: Eosinophil | Change from baseline in total serum target concentrations of eosinophil | From baseline to Day 225 |
| Pharmacodynamic (PD) Characteristics: IgE | Change from baseline in total serum target concentrations of IgE | From baseline to Day 225 |
| Pharmacodynamic (PD) Characteristics: TARC | Change from baseline in total serum target concentrations of TARC | From baseline to Day 225 |
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | 200040 | China |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |