A Randomized, Multicenter, Active-controlled Openlabelled, Multiple-Dose, Dose Finding, Parallel Group Trial, Investigating the Efficacy, Safety, Immunogenicity, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Different Weekly Doses of ALT-P1 Compared to Daily Growth Hormone Treatment of GENOTROPIN® (Somatropin) for Injection in Growth Hormone Treatment naive Prepubertal Children with Growth Hormone Deficiency. - NIL

开始日期2024-09-16

申办/合作机构

Cristália Produtos Químicos Farmacêuticos Ltda.

[+1]

NCT05739734 / Not yet recruiting早期临床1期

Clinical Safety Study of the Application of CRIS100 in Participants With Acute Spinal Cord Injury

The goal of this clinical trial is to test CRIS100 treatment in participants with acute thoracic spinal cord injury. The main questions it aims to answer are:
safety of CRIS100
efficacy of CRIS100
Participants will receive 75 mcg CRIS100 in the epicenter of the spinal injury, within 72 hours of the trauma.

开始日期2023-05-15

申办/合作机构

Cristália Produtos Químicos Farmacêuticos Ltda.

NCT03883763 / Recruiting临床3期

Non-inferiority Study of Hyperbaric Novabupi® (Bupivacaine S75: R25) Compared to Hyperbaric Neocaine® (Bupivacaine S50: R50) in Spinal Anesthesia in Lower Limbs Vascular Surgery

This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery.
The schedule consists of four visits: screening (visit 1); pre-anesthetic evaluation and randomization (visit 2); treatment (visit 3) and discharge from study (visit 4).

开始日期2022-04-01

申办/合作机构

Cristália Produtos Químicos Farmacêuticos Ltda.

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项与 Cristália Produtos Químicos Farmacêuticos Ltda. 相关的文献（医药）

2021-02-01·Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society

Switching from originator recombinant growth hormone (Genotropin™) to biosimilar (CRISCY™): Results from a 6-month, multicentric, non-inferiority, extension trial.

Article

作者: Alegria, M C ; Afiune, J ; Czepielewski, M A ; Spinola-Castro, A M ; Baradelli, R ; Neves, A C L ; Wassermann, G E ; Rodrigues, D G ; Faria, M S ; Leite, N R ; Bronstein, M D ; Toffoletto, O ; Rassi, N ; Garret, Q ; Scharf, M ; Cerqueira, M J A G ; Vencio, S A C ; Senn, C C P ; Cunha, M P R

OBJECTIVE:

A previous 12-month comparative trial with Criscy™ (r-hGH Cristália), a biosimilar recombinant growth hormone, demonstrated equivalent efficacy and safety to Genotropin™. This extension trial evaluated the effects of switching patients treated with Genotropin™ to the biosimilar Criscy™ over an additional 6-month treatment period, comparing efficacy, safety, and immunogenicity parameters with patients remaining in the Criscy™ arm.

DESIGN:

This extension study included 11 research centers and 81 patients who participated in the CERES study (Czepielewski et al., 2019 [1]). Participants from the Genotropin™ arm (n = 39) had the drug replaced by Criscy™ and the remaining participants were kept in the Criscy™ arm (n = 42) for an additional 6-month period to evaluate immunogenicity, efficacy (growth rate, height SDS), and safety (laboratory tests, and adverse events).

RESULTS:

Before the switch, both Criscy™ and Genotropin groups were similar concerning demographics, and auxological measures: age, sex, height, height SDS, weight, and BMI. Height velocity (HV) after 18 months of treatment was 8.7 ± 1.56 cm/year for Criscy™ group and 8.9 ± 1.36 cm/year for Genotropin™ group in the ITT population (p = 0.43). The auxological parameters and IGF-1 and IGFBP-3 SDS were comparable between both groups of patients. No participants were excluded from the study due to adverse events. There were no clinical or statistical relevant differences between the treatment groups concerning frequency, distribution, intensity, and AEs outcome. Similarly, no new anti-r-hGH (ADA) cases among patients that switched from Genotropin™ to Criscy™ were reported. No neutralizing antibody (nAb) was detected in either group.

CONCLUSIONS:

This trial showed that switching from originator recombinant human growth hormone to Criscy™ had no impact on efficacy, safety, nor immunogenicity as compared to continued treatment with Criscy™. Growth rates and ADA incidence remained the same as seen before the switch.

2020-01-02·Preparative biochemistry & biotechnology

Obtainment of an enriched fraction of Inga edulis: identification using UPLC-DAD-MS/MS and photochemopreventive screening

Article

作者: Rogez, Hervé ; Alves, Georgia de Assis Dias ; Fernandes da Silva, Daniele ; Fonseca, Maria José Vieira ; Venteu Teixeira, Thainá ; de Souza, Rebeca Oliveira

Inga edulis is a fruit tree native from Central and South America. Different species of Inga have demonstrated high polyphenolic content and high antioxidant capacity. The oxidative stress significantly contributes to the development of several chronicle diseases, particularly age-related diseases. Therefore, photochemoprevention is an emerging interest in the use of naturally occurring antioxidants for their therapeutic use. A partial purification of the extract was carried out onto macroporous resin and the main components of I. edulis leaf extract and fraction were identified using UPLC-DAD-MS/MS as epicatechin, apigenin C-di-hexoside, myricetin-O-hexose-deoxyhexose, myricetin-O-deoxyhexose and vicenin-2, which was identified for the first time in I. edulis. Both extract and fraction presented high antioxidant capacity, the fraction exhibiting higher polyphenol and flavonoid contents and higher content of vicenin-2, suggesting that the fractioning process effectively resulted in the partial purification of the extract. The cytotoxicity and photostability were assessed in L929 fibroblast cells to evaluate whether I. edulis extract and fraction were suitable for topical application. The UVA and UVB irradiated extract and fraction did not decrease the antioxidant capacity and cell viability of L929 fibroblasts, demonstrating the photostability of the samples. The fractioning process successfully purified and enriched I. edulis extract, and both the extract and fraction are potential candidates to be safely incorporated in topical photochemopreventive formulations.

2020-01-01·Journal of nanoparticle research : an interdisciplinary forum for nanoscale science and technology4区 · 材料科学

Macrophage-like THP-1 cells show effective uptake of silica nanoparticles carrying inactivated diphtheria toxoid for vaccination

4区 · 材料科学

Article

作者: Huang, Xinyue ; Cavalcante, Danielle Paixão ; Townley, Helen E

Abstract:

Nanoparticles may be used in vaccinology as an antigen delivery and/or an immunostimulant to enhance immunity. Porous silica has been identified as an effective adjuvant for more than a decade, and we have therefore investigated the take up rate by an immortalized macrophage-like cell line of a number of mesoporous silica nanoparticles (MSNPs) with differing diameter and pore size. The MSNPs were synthesized using a sol-gel reaction and post-synthesis removal of the template. The MSNPs showed a clear distribution in take up rate peaking at 217 nm, whereas a comparison with solid spherical nanoparticles showed a similar distribution peaking at 377 nm. The MSNPs were investigated before and after loading with antigen. Diphtheria toxoid was used as a proof-of-concept antigen and showed a peak macrophage internalization of 53.42% for loaded LP3 particles which had a diameter of 217.75 ± 5.44 nm and large 16.5 nm pores. Optimal MSNP sizes appeared to be in the 200–400 nm range, and larger pores showed better antigen loading. The mesoporous silica particles were shown to be generally biocompatible, and cell viability was not altered by the loading of particles with or without antigen.

项与 Cristália Produtos Químicos Farmacêuticos Ltda. 相关的新闻（医药）

2024-01-29

·Pharmaceutical Technology

Cristália signs licensing deal for Formosa’s APP13007

APP13007 is intended to treat inflammation and pain following ocular surgery. Credit: elenavolf / Shutterstock.com. Cristália Produtos Químicos Farmacéuticos has signed an agreement to license exclusive rights to market Taiwanese company Formosa Pharmaceuticals’ APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) in Brazil. APP13007 is intended to treat inflammation and pain following ocular surgery. The agreement covers the Brazilian market and includes upfront development milestones and sales-based royalty payments other than further deal-associated payments. APP13007 is under review by the US Food and Drug Administration with a decision on the approach under the Prescription Drug User Fee Act expected on 4 March 2024. The active ingredient in the drug is a superpotent corticosteroid known as clobetasol propionate. It is based on Formosa Pharma’s APNT nanoparticle formulation platform. The new formulation of APP13007 allows for a suitable dosing regimen of twice daily for 14 days. It has demonstrated quick and lasting inflammation and pain relief in Phase III clinical trials, showing statistical and clinical superiority versus placebo. APP13007 will enter the Brazilian market for topical ophthalmic steroids. Cristália chairman Ricardo Pacheco stated: “We are pleased to have entered into this agreement with our development partner, Formosa Pharmaceuticals. “If approved, APP13007 will be an attractive new treatment option to ophthalmic surgeons and their patients in Latin America with a convenient posology [determination of appropriate dosage]. Once it is approved, Cristália will go full steam ahead with commercialisation.” Formosa’s APNT technology enhances the dissolution and bioavailability of active pharmaceutical ingredients across a range of administration methods including topical, oral and inhalation. The platform ensures increased uniformity, purity and stability in formulations, enabling the use of poorly soluble or highly potent drug agents that may otherwise encounter significant challenges in delivery and penetration to target tissues. Formosa Pharmaceuticals president and CEO Erick Co stated: “We are honoured to establish this partnership with Cristália, with its storied history in Brazilian pharmaceuticals and expertise in eye health. “Given their dedication to bringing innovation to the market, we are confident APP13007 will reach its potential in providing ophthalmologists and patients a powerful option in recovering from ocular surgery.”