A phase I double-blind, randomised, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and immunogenicity of PolyCAb in healthy subjects following single doses and one cohort of multiple dosing

开始日期2015-12-15

申办/合作机构

MicroPharm Ltd.

100 项与 PolyCAb 相关的临床结果

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100 项与 PolyCAb 相关的转化医学

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100 项与 PolyCAb 相关的专利（医药）

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项与 PolyCAb 相关的文献（医药）

2011-05-01·The Journal of Nutrition2区 · 医学

Ovine Serum Immunoglobulin Has Immunomodulatory Effects in Growing Rats Gavaged with Salmonella enteritidis1

2区 · 医学

Article

作者: Kyoung-Sik Han ; Harjinder Singh ; Prabhu Balan ; Paul J. Moughan ; Kay Rutherfurd-Markwick

In this study, we aimed to determine whether orally administered ovine serum Ig modulate aspects of immunity and associated gut microflora in growing rats challenged with Salmonella enteritidis. The 4 groups consisted of rats fed a casein-based control diet (BD; ungavaged) and 3 groups of rats gavaged with 1 × 10(7) viable Salmonella enteritidis and fed a BD diet, a BD diet containing freeze-dried ovine Ig (FDOI), or a BD diet containing inactivated ovine Ig (IOI). The rats were randomly allocated to 1 of the 4 diets (n = 15) and consumed it for 18 d. They were orally gavaged on d 15. Phagocytic activity of peripheral blood leukocyte and lymphocyte proliferation in the presence of the concanavalin A (ConA) were greater (P < 0.05) in the ungavaged BD- and gavaged FDOI-fed rats than in the gavaged rats fed either the BD or IOI diet. ConA-stimulated Peyer's patch cells and splenocytes from the gavaged rats fed the FDOI diet produced more IFNγ, IgA, and IgG than the gavaged rats fed either the BD or IOI diet (P < 0.05). The gavaged FDOI-fed rats had higher ileal and colonic digesta and plasma concentrations of anti-Salmonella secretory sIgA and secretory sIgG (P < 0.05). DNA analysis of a denatured gradient gel electrophoresis profile revealed that 6 of 10 bands had sequence similarity to probiotic strains of bacteria in the ileum and colon of the gavaged FDOI-fed rats. In conclusion, an ovine Ig fraction modulated various indices of immune function and associated gut microflora in growing rats inoculated with Salmonella.

2009-02-01·The Journal of Nutrition2区 · 医学

Orally Administered Ovine Serum Immunoglobulins Influence Growth Performance, Organ Weights, and Gut Morphology in Growing Rats

2区 · 医学

Article

作者: Harjinder Singh ; Shane M. Rutherfurd ; Prabhu Balan ; Paul J. Moughan ; Kyoung-Sik Han

In this study, our aim was to determine whether orally administered ovine serum Ig improved growth performance, organ weights, and gut morphology in growing rats and whether the method of manufacture of ovine serum Ig affected its bioactivity. Ninety Sprague-Dawley male rats were used in a 21-d growth study and were fed a basal control diet (BD; no Ig) and 5 test diets: spray-dried porcine plasma (SDPP), freeze-dried ovine Ig (FDOI), 2 concentrations of spray-dried ovine Ig (SDOI(100) and SDOI(150)), and inactivated ovine Ig (IOI). Diets were isocaloric and contained the same amount of the first limiting amino acids, methionine plus cysteine. The body weight gain:feed ratio was higher (P < 0.05) for the FDOI-fed rats than for the BD- and IOI-fed groups. FDOI rats had higher jejunum (P < 0.05) and colon weights (P < 0.05) at the end of the study than rats in the BD group. Compared with the SDOI(100)-fed group, the FDOI group supported higher (P < 0.05) duodenum and colon weights. For gut morphology, the FDOI and the BD and IOI groups differed (P < 0.05). The FDOI-fed rats had longer (P < 0.05) villi and greater villi surface areas in the duodenum, jejunum, and ileum than the rats fed SDOI(100). An ovine Ig fraction selectively improved growth performance, organ weight, and gut morphology in growing rats. Compared with spray-drying, a freeze-drying procedure appears to preserve a higher degree of immunological activity.

1999-11-12·Journal of Andrology

FSH Immunoneutralization Acutely Impairs Spermatogonial Development in Normal Adult Rats

Article

作者: David M Robertson ; Nigel G Wreford ; Sarah J Meachem ; Peter G Stanton ; Robert I McLachlan

ABSTRACT: Follicle‐stimulating hormone (FSH) plays an important part in testicular development. Its role in the regulation of spermatogenesis in the adult, however, remains controversial. This study aimed to explore the role of FSH in the maintenance of adult rat spermatogenesis by using immunoneutralization to selectively withdraw FSH action for periods of up to 8.5 days and then assessing the outcome by quantification of germ cell number. Adult rats received either an ovine polyclonal rat FSH antibody (FSHAb, 2 mg/ kg subcutaneous daily—a dosage known to neutralize >90% of FSH in serum) for 2, 4, 7, or 8.5 days or a control sheep immunoglobulin (ConAb, 2 mg/kg) for 8.5 days. Testes were perfusion fixed, and germ cell numbers per testis were quantified using the optical disector (sic) stereological method. The percentage of seminiferous tubules displaying apoptotic cells was determined by the in situ end labeling method (TUNEL). FSHAb treatment for 4, 7, or 8.5 days significantly reduced the number of type A/intermediate spermatogonia (∼74% of control values) associated with stages I‐IV. Similar reductions were seen in type B spermatogonial and preleptotene spermatocyte numbers after 8.5 days of FSHAb treatment (∼69% of control values; P < 0.05). Decreases (P 0.05) in the numbers of pachytene spermatocytes in stages I‐III and VIII, round spermatids in stages I‐III, VII, and VIII (∼70% of control values), and step 19 elongated spermatids in stage VII (51% of control values) were achieved after 8.5 days of FSHAb treatment. Compared with control, FSHAb treatment increased the percentage of stage XIV‐III tubules containing TUNEL‐positive cells by about twofold after 7 days of FSHAb treatment (P < 0.05). This study supports a role for FSH in the maintenance of quantitatively normal adult rat spermatogenesis, specifically by regulating A3 and A4 spermatogonial subtypes. FSH may act on these spermatogonia by enhancing the stage‐dependent survival of type A spermatogonia. Effects at other sites in spermatogenesis are suggested by the changes in spermatocyte and spermatid populations. However, to clarify these effects, selective FSH withdrawal would need to be prolonged until steady state had been achieved.

100 项与 PolyCAb 相关的药物交易

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