A Phase 1 interventional study of HB0034 in Generalized Pustular Psoriasis, sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).
This is an open-label, multicenter, phase Ib exploratory study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients presenting moderate-severe generalized pustular psoriasis (GPP ) flare.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 9 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Shanghai Huaota Biopharmaceutical Co., Ltd. is the lead sponsor of 16 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Drug: HB0034
HB0034, a single dose
Also known as: HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Number of patients with drug related adverse events
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
Time frame: 90 days
Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)
efficacy outcome of investigational drug
Time frame: 12 weeks
Cmax
The maximum measured concentration of the analysis in plasma
Time frame: 12 weeks
AUC0-infinity
The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
Time frame: 12 weeks
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Shanghai Huaota Biopharmaceutical Co., Ltd.