Randomized, Double Blind, Placebo Controlled, Incomplete Crossover Single Oral Dose Escalation of PRCL-02 in Normal Healthy Volunteers (Part A) and Multiple Oral Dose Escalation in Normal Healthy Volunteers (Part B) and in Chronic Plaque Psoriasis Patients (Part C)

This study consists of three parts: single oral dose escalation in healthy volunteers (Part A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants with chronic plaque psoriasis (Part C)

开始日期2017-02-20

申办/合作机构

PRCL Research Inc.

100 项与 PRCL-02 相关的临床结果

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100 项与 PRCL-02 相关的转化医学

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100 项与 PRCL-02 相关的专利（医药）

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项与 PRCL-02 相关的文献（医药）

2020-05-01·Transplantation2区 · 医学

Targeting Calcium Release–activated Calcium Channel Is Not Sufficient to Prevent Rejection in Nonhuman Primate Kidney Transplantation

2区 · 医学

Article

作者: Sloan-Lancaster, Joanne ; Song, Mingqing ; Yoon, Janghoon ; Rao, Patricia E ; Park, Jaeberm ; Knechtle, Stuart J ; Ezekian, Brian ; Manook, Miriam ; Fortier, Caroline ; Freischlag, Kyle ; Farris, Alton B ; Kwun, Jean

Background.Calcineurin inhibitors successfully control rejection of transplanted organs but also cause nephrotoxicity. This study, using a rhesus monkey renal transplantation model, sought to determine the applicability of a new immunomodulatory drug inhibiting the store-operated calcium release–activated calcium channel of lymphocytes to control transplant rejection without nephrotoxicity.Methods.Animals underwent kidney transplantation and were treated with tacrolimus alone (n = 3), a CRACM1 inhibitor (PRCL-02) (n = 6) alone, or with initial tacrolimus monotherapy followed by gradual conversion at 3 weeks to PRCL-02 alone (n = 3). PRCL-02 was administered via a surgically inserted gastrostomy tube BID.Results.Dose-related drug exposure in monkeys was established and renal transplants were then performed using PRCL-02 monotherapy. Oral dosing of PRCL-02 was well tolerated and resulted in suppressed T-cell proliferation in in vitro MLR comparable to animals in the tacrolimus control arm. Animals receiving tacrolimus monotherapy were e on day 100 without rejection. PRCL-02 monotherapy only marginally prolonged graft survival (MST = 13.16 d; group 2) compared with untreated controls. Animals treated initially with tacrolimus and converted to PRCL-02 monotherapy had a mean graft survival of 35.3 days which was prolonged compared with PRCL-02 monotherapy but not compared with the tacrolimus-treated group. Pharmacokinetic studies showed inconsistent drug exposures despite attempts to adjust dose and exposure which may have contributed to the rejections.Conclusions.We conclude that, in this nonhuman primate model of kidney transplantation, PRCL-02 demonstrated evidence of in vivo immunosuppressive activity but was inferior to tacrolimus treatment with respect to suppressing immune transplant rejection.

100 项与 PRCL-02 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
银屑病	临床2期	-	Madrigal Pharmaceuticals, Inc.	-
斑块状银屑病	临床前	加拿大	PRCL Research Inc.	2018-09-25
斑块状银屑病	临床前	斯洛伐克	PRCL Research Inc.	2018-09-25
斑块状银屑病	临床前	乌克兰	PRCL Research Inc.	2018-09-25
寻常性银屑病	临床前	斯洛伐克	PRCL Research Inc.	2018-09-25
寻常性银屑病	临床前	加拿大	PRCL Research Inc.	2018-09-25
寻常性银屑病	临床前	乌克兰	PRCL Research Inc.	2018-09-25

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03614078 (CTgov)	临床2期	斑块状银屑病 \| 寻常性银屑病	92	Placebo	夢簾糧糧憲鬱鏇窪衊積(憲製願遞齋範鹽廠夢鬱) = 憲繭製憲鬱鬱遞積網餘憲衊襯鬱遞膚範膚窪憲 (鹹淵襯衊壓製糧醖艱醖, 築艱衊艱膚艱鑰鏇願積 ~ 蓋糧壓齋糧網築積觸鹹) 更多	-	2020-03-30