Sentences with phrase «dose safety study»
Proclara recently completed a Phase 1a single - dose safety study of NPT088 in 40 healthy volunteers.
http://www.proclarabio.com/ Not exact matches
And in the recent randomized study — which was designed to assess the safety and tolerability of various doses in volunteers from Canada, Germany, and the UK — IONIS - HTTRx appeared to substantially block the gene's pernicious message from getting through.
«American effort reduced risky opioid prescriptions for veterans, study finds: Reductions in highest doses through computer «dashboard» and prioritizing painkiller safety suggests other large health systems could do the same.»
And they conclude that «additional studies focusing not only on subgroup specific effectiveness and safety but also on optimal dosing schemes are needed.»
According to Dunbar, the next logical step would be to take evinacumab into larger clinical trials to study its safety, effectiveness, and optimal dosing.
The imaging software — developed and currently in use only at Cincinnati Children's — mathematically determines the lowest possible radiation dose for the patient before a scan is performed, according to the study led by David Larson, MD, radiology quality and safety director at the medical center and principal architect of the technology.
This study was a randomized, double - blind, placebo - controlled trial designed to characterize the safety, tolerability and pharmacokinetics of AVI - 7288 after daily repeat dosing.
The standard pharmaceutical development path for products that target pathogens moves slowly from studying safety, dosing, and biological responses in hundreds of people to an expensive efficacy trial with thousands of participants at high risk of becoming naturally infected.
The safety study sets the stage for phase II clinical trials looking at whether high dose vitamin C is effective at extending overall lifespan and quality of life for patients undergoing radiation and chemotherapy.
His team is winding up a safety study in which 40 patients breathed in a single dose of a lipid - CFTR DNA mixture.
A recent study by Paul Armstrong at the Department of Health, Western Australia, and colleagues reported that the rate of febrile convulsions among young children was 3.3 per 1000 doses, 200 times that reported in a U.S. influenza vaccine safety study.
Our study results suggest that this could be an effective wheezing prevention strategy following infant viral ARIs, however, research would first need to be done to determine the effects, adequate dosing and safety of certain antioxidant agents in infants before they can be recommended for this use.»
Phase I studies focus on questions related to the safety and best dose of experimental therapies.
The first independent studies of Japan's worst nuclear accident, which has already caused the death of two workers from multiple organ failure, also suggest that radiation doses outside the 350 - metre evacuation zone breached the safety limit.
Additionally, in comparison to by - passing agents, emicizumab is easier to administer, requires less frequent dosing, and based on this study, appears to have an improved safety profile.»
A Phase 1/2, Open - Label, Dose - Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies
The Phase 1 study of ISIS - SMNRx is a single - dose, dose - escalation study designed to assess the safety, tolerability and pharmacokinetic profile of the drug in children with SMA between the ages of 2 - 14 who are medically stable.
Timed sequential treatment with cyclophosphamide, doxorubicin, and an allogeneic granulocyte - macrophage colony - stimulating factor - secreting breast tumor vaccine: a chemotherapy dose - ranging study of safety and immune activation.
A Phase I / II, Open - label, Multi-center Study of the Safety and Efficacy of IMCgp100 using the Intra-patient Escalation Dosing Regimen in Patients with Advanced Uveal Melanoma
The primary objective of this study is to determine the safety and maximum - tolerated dose of P - BCMA - 101.
An Open - Label, Multicenter Phase I Study to Characterize the Safety, Tolerability, Preliminary Anti-Tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY 1251152 in Patients with Advanced Hematological Malignancies
A Multi-arm, Phase Ib, Open - Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Combination with Ascending Doses of Novel Therapeutics in Patients with EGFRm + Advanced NSCLC who have progressed following therapy with an EGFR TKI (TATTON)
Part 1 of the study is a double - blinded, placebo - controlled, randomized exploratory dose - finding study in approximately 36 patients for 12 weeks to evaluate the safety of RG7916 and to select the dose for Part 2 of the study.
The Phase 1 open - label, multicenter, dose escalation study of mRNA - 2416 is designed to determine the safety and tolerability of escalating iTu doses of mRNA - 2416 in patients with relapsed / refractory solid tumor malignancies or lymphoma, and define the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) and schedule for iTu injections of mRNA - 2416.
It is also a two - part study with the first part being an open - label dose escalation study in at least 8 infants for 4 weeks to evaluate the safety profile of RG7916 and to determine the dose for Part 2.
The first Phase 1 study of this vaccine in a malaria - exposed population found it to have promising safety and tolerability profiles in adults in Bandiagara, Mali, and to elicit dose - dependent anti-AMA1 antibody responses [17] as well as IL - 5 production and lymphocyte proliferative responses [22].
The randomized, double - blind, placebo - controlled study will evaluate the safety and tolerability of multiple doses of NPT088, as well as pharmacokinetics, immunogenicity and pharmacodynamic characteristics, as measured by Aβ and tau PET imaging.
Prothena announced the dosing of the first Phase Ia subject on April 8, 2014; they appear to have been successful in recruiting subjects and to have quickly derived favorable safety signals, as they announced the dosing of the first PD volunteer in the Phase Ib trial on July 31, 2014, «based upon safety and tolerability observed to date in the ongoing study in healthy volunteers.»
Safety and tolerability of a novel, polyclonal human anti-MERS coronavirus antibody produced from transchromosomic cattle: a phase 1 randomised, double - blind, single - dose - escalation study.
Acute toxicity studies showed no oral toxicity of J147 in mice at the maximum testable dose of 2 gm / kg and other safety tests including hERG, CYP450 inhibition and Ames were also negative which further supports the safety of J147.
Asterias has dosed 25 subjects with AST - OPC1 in the SCiStar study and a total of 30 subjects including the five subjects from the previous Phase 1 safety trial.
The purpose of Part 2 is to determine if the dose and treatment cycle of the Study Drug chosen from Part 1 is effective for treating specific types of cancer while gathering additional safety data.
There will be at least a four - week interval between the dosing of the first three patients for each dose being studied and, based on the available safety data, a decision will be made whether to proceed.
The Phase 1b / 2a study of ISIS - SMNRx is a multiple - dose, dose - escalation study designed to assess the safety, tolerability and pharmacokinetic profile of the drug in children with SMA between the ages of 2 - 15 who are medically stable.
There are two parts to this study: - Phase Ib: To determine the safety and side effects of increasing doses of IL - 2 in combination with pembrolizumab - Phase II: Once the maximum tolerated dose of IL - 2 is determined, additional patients will be treated to determine if it is effective against the cancer.
Interim data from 17 patients confirmed the safety and brain penetration of EOS200271 at doses ranging up to 500 mg BID, the maximum dose tested by Pfizer in the study.
Phase I Trials initial studies to determine the safety and pharmacologic actions of drugs in humans, and the side effects associated with increasing doses; in some cases can also be used to gain early evidence of effectiveness.
Acute and subacute toxicity study of 1,8 - cineole in mice Antimicrobial activity of essential oils and other plant extracts In Vitro Antibacterial Activity of Essential Oils against Streptococcus pyogenes In vitro antibacterial activity of some plant essential oils A near fatal case of high dose peppermint oil ingestion - Lessons learnt National Association for Holistic Aromatherapy Data Safety Sheet for Essential Oils during pregnancy International Association of Professional Aromatherapists Pregnancy Data Sheet (PDF) Robert Tisserand
A Phase II Study on Safety and Efficacy of High - dose N - acetylcysteine in Patients with Cystic Fibrosis.
«A dose escalation study was conducted to determine the maximum tolerated dose and safety of a single dose of standardized powder extract, uniformly milled curcumin -LRB-
A masked, multisite, well - controlled study of 436 dogs conducted at 26 veterinary clinics in the US evaluated the effectiveness and safety of APOQUEL, dosed orally twice daily (BID) at 0.4 to 0.6 mg / kg for the control of pruritus associated with allergic dermatitis, including flea allergy, food allergy, contact allergy and atopic dermatitis
A randomized, blinded, placebo - controlled pivotal field study to evaluate the effectiveness and safety of robenacoxib (tablets) when administered at a dose of 2 mg / kg once daily for 3 days for the control of postoperative pain and inflammation associated with soft - tissue surgery in dogs.
In a 9 - day target animal safety study, 4 - month - old healthy cats (4 / sex / group; n = 32) were administered SIMBADOL ™ (buprenorphine injection) subcutaneously at 0X (saline), 1X (0.24 mg / kg), 3X (0.72 mg / kg) or 5X (1.2 mg / kg) once daily.1 «Zoetis recommends use at label dose of 0.24 mg / kg and duration of up to 3 days.»
Safety considerations in the design and interpretation of clinical trials indicates that «some animal studies have suggested the potential for dose - dependent fetal toxicities (for example, growth impairment, skeletal malformations and cardiovascular anomalies) associated with excess Vitamin D supplementation.
Our New Safety Study showed that at 4,000 times the normal dose for 90 days there were no adverse events.
The majority of adverse events were mild in severity and similar to the placebo group in frequency.6 In a separate safety study, SIMBADOL was well tolerated at up to five times the label dose for up to nine days.7
In animal safety studies, dogs under six months of age were prone to neurological symptoms which ceased at six months of age; in the animal safety studies, some dogs receiving three times and five times the recommended dose exhibited neurological symptoms including tremors, ataxia and seizures (prescribing information on the link below).
Efficacy was confirmed in a one - year duration of immunity study in which none of the vaccinated animals were infected with rabies when challenged 12 months after a single dose of DEFENSOR.4 During a field safety study conducted in 200 ferrets, no significant post-vaccination reactions were observed.5
SAFETY: Studies with ivermectin indicate that certain dogs of the Collie breed are more sensitive to the effects of ivermectin administered at elevated dose levels (more than 16 times the target use level of 6 mcg / kg) than dogs of other breeds.
Additionally, a 9 - month study in which Galliprant was administered to healthy dogs at approximately 15 times the labeled 2 mg / kg dose, demonstrated the product's safety.