A Phase Ia Clinical Study of HIV Entry Inhibitor CPT31: Single Ascending Dose Study of Safety, Tolerability, Immunogenicity, and Pharmacokinetics in Healthy Adults

This first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of the HIV entry inhibitor CPT31 (cholesterol-PIE12-2-trimer) in healthy adults. This is a randomized, placebo-controlled, double-blind, single ascending dose study.

开始日期2020-11-16

申办/合作机构

Navigen, Inc.初创企业

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100 项与 CPT-31 相关的临床结果

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100 项与 CPT-31 相关的转化医学

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100 项与 CPT-31 相关的专利（医药）

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项与 CPT-31 相关的文献（医药）

2023-05-16·Proceedings of the National Academy of Sciences of the United States of America1区 · 综合性期刊

Zinc treatment reverses and anti-Zn-regulated miRs suppress esophageal carcinomas in vivo.

1区 · 综合性期刊

Article

作者: Brydges, Christopher R ; Fong, Louise Y ; Fiehn, Oliver ; Smalley, Karl J ; Farber, John L ; Croce, Carlo M ; Jing, Ruiyan ; Huebner, Kay

Esophageal squamous cell carcinoma (ESCC) is a deadly disease with few prevention or treatment options. ESCC development in humans and rodents is associated with Zn deficiency (ZD), inflammation, and overexpression of oncogenic microRNAs: miR-31 and miR-21. In a ZD-promoted ESCC rat model with upregulation of these miRs, systemic antimiR-31 suppresses the miR-31-EGLN3/STK40-NF-κB-controlled inflammatory pathway and ESCC. In this model, systemic delivery of Zn-regulated antimiR-31, followed by antimiR-21, restored expression of tumor-suppressor proteins targeted by these specific miRs: STK40/EGLN3 (miR-31), PDCD4 (miR-21), suppressing inflammation, promoting apoptosis, and inhibiting ESCC development. Moreover, ESCC-bearing Zn-deficient (ZD) rats receiving Zn medication showed a 47% decrease in ESCC incidence vs. Zn-untreated controls. Zn treatment eliminated ESCCs by affecting a spectrum of biological processes that included downregulation of expression of the two miRs and miR-31-controlled inflammatory pathway, stimulation of miR-21-PDCD4 axis apoptosis, and reversal of the ESCC metabolome: with decrease in putrescine, increase in glucose, accompanied by downregulation of metabolite enzymes ODC and HK2. Thus, Zn treatment or miR-31/21 silencing are effective therapeutic strategies for ESCC in this rodent model and should be examined in the human counterpart exhibiting the same biological processes.

2020-09-08·Proceedings of the National Academy of Sciences1区 · 综合性期刊

Prevention and treatment of SHIVAD8 infection in rhesus macaques by a potent d -peptide HIV entry inhibitor

1区 · 综合性期刊

Article

作者: Smith, Amanda R. ; Donau, Olivia K. ; Kay, Michael S. ; Francis, J. Nicholas ; Jesteadt, Eric ; Seaman, Michael S. ; Welch, Brett D. ; Martin, Malcolm A. ; Nishimura, Yoshiaki ; Sadjadpour, Reza

Significance This paper characterizes a d -peptide HIV entry inhibitor, CPT31, in rhesus macaques. This nonhuman primate animal model provides the most robust evaluation of an in vivo antiviral prior to human trials. As described here, CPT31 is a promising HIV drug candidate because of its high potency and breadth, long half-life, and strong activity in this macaque model (both as a preventative and therapeutic agent). The efficacy data described here complete CPT31’s preclinical studies, with clinical trials scheduled to start this year. These data also help establish d -peptides as an emerging class of therapeutics.

2018-04-01·Domestic Animal Endocrinology2区 · 农林科学

Steroidogenic factor-1 inverse agonists as a treatment option for canine hypercortisolism: in vitro study

2区 · 农林科学

Article

作者: Galac, S ; Slob, A ; Sanders, K ; Kooistra, H S ; Mol, J A

Hypercortisolism is one of the most commonly diagnosed endocrinopathies in dogs, and new targeted medical treatment options are desirable. Steroidogenic factor-1 (SF-1), an orphan nuclear hormone receptor, is a key regulator of adrenal steroidogenesis, development, and growth. In pituitary-dependent hypercortisolism (PDH), high plasma ACTH concentrations increase the transcriptional activity of SF-1. In adrenal-dependent hypercortisolism, SF-1 expression is significantly greater in dogs with recurrence after adrenalectomy than in those without recurrence. Inhibition of SF-1 could therefore be an interesting treatment option in canine spontaneous hypercortisolism. We determined the effects of 3 SF-1 inverse agonists, compounds IsoQ A, #31, and #32, on cortisol production, on the messenger RNA (mRNA) expression of steroidogenic enzymes and SFs, and on cell viability, in primary adrenocortical cell cultures of 8 normal adrenal glands and of 3 cortisol-secreting adrenocortical tumors (ATs). To mimic PDH, the normal adrenocortical cell cultures were stimulated with ACTH. The results show that only compound #31 inhibited cortisol production and SF-1 target gene expression in non-ACTH-stimulated and ACTH-stimulated normal adrenocortical cells but did not affect cell viability. In the AT cell cultures, the effects of #31 on cortisol production and target gene expression were variable, possibly caused by a difference in the SF-1 mRNA expressions of the primary tumors. In conclusion, inhibition of SF-1 activity shows much promise as a future treatment for canine hypercortisolism.

100 项与 CPT-31 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
HIV感染	临床1期	美国	Navigen, Inc.初创企业	2020-11-16

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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


NCT04672083 (CTgov)	临床1期	HIV感染	32	CPT31 (Cohort 1 0.01 mg/kg CPT31)	願膚艱範壓願積製膚窪(構積夢鏇獵築夢淵窪蓋) = 積廠築襯淵獵糧餘廠鏇艱廠蓋製顧壓鑰繭觸窪 (獵艱鹽膚獵襯鏇餘顧鹽, 膚憲壓選簾鏇憲鏇製簾 ~ 積鬱鬱蓋製選網壓鑰顧) 更多	-	2023-02-21
				CPT31 (Cohort 2 0.04 mg/kg CPT31)	願膚艱範壓願積製膚窪(構積夢鏇獵築夢淵窪蓋) = 廠網餘鑰憲積築壓積鹹艱廠蓋製顧壓鑰繭觸窪 (獵艱鹽膚獵襯鏇餘顧鹽, 艱衊製選齋鑰網顧構遞 ~ 製蓋選鏇衊餘築鏇獵鏇) 更多