ObjectiveThis phase I study of ZYAN1 was conducted to evaluate the safety, tolerability, and pharmacokinetics following oral administration in healthy volunteers.MethodsThe study was a randomized, double-blind, placebo-controlled phase I study carried out in two parts in addition to a third part involving an open-label study to evaluate the food/sex effect. A total of 100 subjects were enrolled into the study as follows: part I—single-dose study with ZYAN1 10, 25, 50, 100, 150, 200, and 300 mg (n = 56); part II—multiple-dose study with every other day dosing of ZYAN1 100, 150, 200, and 300 mg (n = 32); and part III—sex and food effect study with ZYAN1 150 mg (n = 12; open-label).ResultsZYAN1 was well-tolerated after single and multiple oral ascending doses. No drug-related serious adverse events were reported. Following a single ascending dose of ZYAN1, the maximum concentration (C max) ranged from 566.47 ± 163.03 to 17,858.33 ± 2899.19 ng/mL and the median time to C max (t max) was approximately 2.5 h for the studied 30-fold oral doses of ZYAN1. Regardless of single or multiple doses, mean C max and area under the concentration–time curve from time zero to time t (AUCt) values generally showed a dose-proportional increase. The mean elimination half-life (t ½) of ZYAN1 ranged from 6.9 to 13 h with negligible accumulation. Following a single dose of ZYAN1, the mean serum erythropoietin (EPO) C max values showed dose response (i.e., 6.6 and 79.9 mIU/L for 10 and 300 mg ZYAN1 doses, respectively), while the time to mean maximal serum EPO concentrations ranged from 10 to 72 h.ConclusionOral single (10–300 mg) and multiple dosing (100–300 mg) of ZYAN1 in healthy subjects was found to be safe and well-tolerated. With increasing ZYAN1 dose, there was almost a proportional increase in mean C max and AUCt. The mean serum EPO concentrations showed a trend of dose response. Based on the t ½, pharmacodynamic activity, and lack of drug accumulation, a once every 2 days dosing regimen of ZYAN1 was appropriate for phase II study. Trial Registration: Australian New Zealand Clinical Trials Registry trial ID ACTRN12614001240639.

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Premenstrual syndrome (PMS) is defined as the recurrence of psychological and physical symptoms in the luteal phase, which remit in the follicular phase of the menstrual cycle. Symptoms of which fall in three domains: emotional, physical and behavioural e.g. irritability, anger, headache, fatigue, food cravings etc. The survey study of was conducted among 50 young & 50 middle aged women of S.B.K.S Medical Institute and Research Centre to find the prevalence of premenstrual syndrome with an emphasis on its management. Responses to a feedback questionnaire covering various aspects related PMS were obtained from 50 participants belonging to each group. The participants belonged to different range of literacy. It was found that 42% faced PMS regularly, while 58% occasionally. Of the 100 participants 68% suffered with backache, 64% leg cramps, 62% fatigue, breast tenderness and anger whereas 58% suffered with anxiety and generalized body ache. Of all the sufferers only 34% had received the treatment for PMS. Irrespective of the age PMS is common problem faced by women. With our study we observed that literacy has not mattered in the management of this health problem. Since there are reports stating that the severity of PMS can hamper the daily routine and even lead to suicidal tendency, it is essential that awareness programs need to be conducted to address the importance of managing the issue by pharmacological and non-pharmacological methods. [Int J Res Med Sci 2013; 1(2.000): 69-72

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Background COVID-19 hyper-immune globulin (HIG) solution is a human plasma-derived, highly-purified, concentrated, virus-inactivated preparation of neutralizing antibodies (NAbs) against COVID-19. Methods This was a randomized, two-arm, controlled, multi-center trial to evaluate the efficacy and safety of COVID-19 HIG in patients who were hospitalized with moderate-severe COVID-19 infection. Results A total of 60 patients were randomized (30 in each arm). Overall, COVID-19 HIG was well-tolerated without any serious treatment-emergent adverse event or tolerability issue. The mean change in ordinal scale by day 8 was 1.7±1.61 in the test arm vs. 2.0±1.68 in the control arm (mITT; p=0.367). Early and high NAbs were observed in the test arm compared to the control arm. More patients had negative RT-PCR by day 3 for the test arm vs. the control arm (mITT: 46.67% in test vs. 37.93% in control). The median time to be RT-PCR negative was 5.5 days for the test arm vs. 8.0 days for the control arm for PP population. Patients receiving COVID-19 HIG showed early improvement (reduction) in the biomarkers (CRP, IL-6, and D-dimer). Conclusion COVID-19 HIG was found to be safe and well-tolerated. Early and high NAbs were achieved in COVID-19 HIG recipients qualifying the product as a suitable treatment option, particularly in an immunocompromised state. It should be given early in infection to mitigate progression to severe disease. It should be evaluated for post-exposure prophylaxis as well as for prevention (where a vaccine is not suitable or effective). It should be evaluated in the pediatric population as well.