A Phase I, Double-Blind, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1634 vs Placebo Administered Intravenously in Healthy Adults

This study evaluates the safety and pharmacokinetics of NTM-1634 in healthy subjects.

开始日期2017-03-20

申办/合作机构

Resilience Government Services, Inc.

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100 项与 NTM-1634 相关的临床结果

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100 项与 NTM-1634 相关的转化医学

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100 项与 NTM-1634 相关的专利（医药）

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111

项与 NTM-1634 相关的文献（医药）

2024-10-01·Anaerobe

Immunogenicity of a pentavalent recombinant Escherichia coli bacterin against enterotoxemia and botulism in sheep

Article

作者: Alves, Mariliana Luiza Ferreira ; Ferreira, Marcos Roberto A ; Donassolo, Rafael Amaral ; Moreira Júnior, Clóvis ; Conceição, Fabricio Rochedo ; Feijó, Fernanda Dornelles ; Waller, Stefanie Bressan ; Rodrigues, Rafael Rodrigues ; Motta, Jaqueline Freitas

INTRODUCTIONProducing commercial bacterins/toxoids against Clostridium spp. is laborious and hazardous. Conversely, developing prototype vaccines using purified recombinant toxoids, though safe and effective, is both laborious and costly for application in production animals.OBJECTIVEConsidering that inactivated recombinant Escherichiacoli (bacterin) is a simple, cost-effective, and to be safe solution, we evaluated, for the first time, a pentavalent formulation of recombinant bacterins containing the alpha, beta, and epsilon toxins of Clostridiumperfringens and C and D neurotoxins of Clostridiumbotulinum in sheep.METHODSSubcutaneously, 18 Texel sheep received two doses (200 μg of each antigen) of recombinant bacterin (n = 7) or purified recombinant antigens (n = 6) on days 0 and 28, while the control group (n = 5) did not receive an immunization. Sera samples from days 0 (before the 1st dose), 28 (before the 2nd dose), and 56, 84, and 112 were used for measuring IgG (indirect ELISA) and neutralizing antibodies (mouse serum neutralization).RESULTSBoth formulations induced significant levels of IgG against all five toxins (p < 0.05) up to day 112, with peaks at days 28 and 56 post-immunization. The expected booster effect occurred only for the botulinum toxins. The neutralizing antibody titers were satisfactory against ETX (≥2 IU/ml for both formulations) and BoNT-D [5 IU/ml (bacterin) and 10 IU/ml (purified)].CONCLUSIONWhile adjustments are required, the recombinant bacterin platform holds great potential for polyvalent vaccines due to its straightforward, safe, and cost-effective production, establishing it as a user-friendly technology for the veterinary immunobiological industry.

2024-09-01·Current Developments in Nutrition

Knowledge, Prevalence, and Consequences of Dietary Supplements Intake among Iranian Bodybuilders

Article

作者: Imanian, Babak ; Jahan, Zeinab ; Hemmatinafar, Mohammad ; Bajool, Yasaman ; Daryanoosh, Farhad ; Jahaniboushehri, Nima

BackgroundThis study investigated the nutritional knowledge and prevalence of dietary supplements (DSs) among Iranian bodybuilders.MethodsThis cross-sectional research study involved sampling 648 bodybuilding clubs in Iran. A researcher distributed questionnaires among clubs in various regions and analyzed categorical variables, DS, nutritional knowledge, and sports nutrition data from 160 bodybuilders aged 18 and above in Iran. The analysis was conducted using the results obtained from a quantitative questionnaire.ResultsThere was a significant relationship between DS use and gender (P = 0.001, r = 0.330, males > females), bodybuilding history (P = 0.045; r = 0.158), and exercise sessions/wk (P = 0.050, r = 0.156). Whey protein (45.6%) and branched-chain amino acid (33.7%), vitamin D (50%), caffeine (34.3%), and generally vitamin C (56.2%) were the most common DS used. The most information sources for bodybuilders regarding DS were fitness coaches (35.6%) and registered dietitians/nutritionists (34.3%). Drug stores (36.7%) and fitness coaches (19.3%) were the most prominent sources for purchasing DS. Increasing performance (54.3%), increasing the need for DS through exercise (53.6%), preventing injury, and improving recovery (36.2%) were the most important reasons to consume DS. Skin problems (21.0%), increased liver enzymes (10.8%), and hair loss (9.4%) were the most common side effects of DS use. Total nutritional knowledge (macronutrients, micronutrients, and sports nutrition) was 58.6%.ConclusionsThis study concluded that fitness coaches and registered dietitians/nutritionists were the most common information sources for bodybuilders. It also revealed a moderate level of nutrition knowledge among bodybuilders. The most commonly used DS were vitamins C, D, and whey protein. Also, gender, bodybuilding history, and exercise sessions had a significant relationship with the prevalence of DS. However, the study also revealed some concerning findings; bodybuilders commonly experienced adverse side effects such as skin rashes, increased liver enzymes, and hair loss.

2024-05-10·Cureus

Bifidobacterium Against COVID-19: A Mother and Her Newborn’s Gut Microbiome

Article

作者: Lander, Skye ; Carlson, Abby ; Walters, Camila ; Smith, Megan ; Hazan, Sabine

Several treatments and preventive measures for SARS-CoV-2 were studied during the pandemic, but few focused on the neonatal gut microbiome and its role in the setting of COVID-19. This case report is unique because it describes the gut microbiomes of a mother and her newborn, who both contracted COVID-19 shortly after the baby's birth. In this prospective study, on day 11 postpartum, both the newborn and mother (38 years old), of white race/ethnicity, were exposed to a COVID-19-positive person. After exposure, the mother received a 40,000 IU bolus of vitamin D orally and started a five-day course of high-dose vitamin C (10,000 mg daily), after which she continued her daily combination of vitamins C, D, and zinc pill with probiotic skyr yogurt and manuka honey. Stool specimens and DNA were extracted, quantitated, and normalized from the mother and the newborn for downstream library fabrication utilizing shotgun methodology. Baseline Bifidobacteria level for the mother was 1.5% which increased to 19% on day 15 postpartum after testing positive for COVID-19 and taking vitamin C. Neonatal Bifidobacteriasteadily increased regardless of COVID-19 infection. We propose that the disease course was altered by maternal supplementation of vitamins C and D and zinc, which may have increased Bifidobacterium levels and led to improved outcomes for both patients.

100 项与 NTM-1634 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肉毒中毒	临床2期	美国	National University	-
肉毒中毒	临床1期	-	Harvard Medical School	-
肉毒中毒	临床1期	-	Dana-Farber Cancer Institute, Inc.	-
肉毒中毒	临床1期	-	University of California	-
肉毒中毒	临床1期	-	Resilience Government Services, Inc.	-
严重急性呼吸综合征	临床1期	-	Resilience Government Services, Inc.	-
严重急性呼吸综合征	临床1期	-	University of California	-
严重急性呼吸综合征	临床1期	-	Harvard Medical School	-
严重急性呼吸综合征	临床1期	-	Dana-Farber Cancer Institute, Inc.	-
严重急性呼吸综合征	药物发现	美国	National University	-