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We are hoping that the Phase III programme will further show the efficacy and tolerability of NER1006," commented Donna McVey, Chief Development Officer, Norgine.
The tolerability was rated as 'very good' or 'good' by the investigators for 99% of the subjects, and by 98% of subjects in self-assessment with no statistical differences to placebo," said Barbara Grube, MD, coordinating investigator and lead author of the study.
This first-in-patient study is being conducted in the EU, to determine the safety and tolerability of ADX71149 and to explore the potential clinical effect of this mGluR2 PAM in patients with schizophrenia.
CH-1504, a non-metabolized antifolate, is engineered to provide the same potent efficacy as MTX but without the side effects caused by the metabolic breakdown of MTX into by-products that are believed to play a significant role in the liver and kidney toxicities and tolerability related side effects associated with chronic therapy.
Reverset is clearly a very potent and potentially important new HIV therapy with its once-a-day formulation, good tolerability and activity against key mutations.
An adolescent program (for girls 9-15 years of age) is ongoing to demonstrate vaccine immunogenicity and tolerability in boys and girls.
Safety, tolerability, and pharmacokinetics of a novel, small-molecule HIV-1 attachment inhibitor, BMS-488043, after single and multiple oral doses in healthy subjects.
In several studies, a dose of 10 (11) virus particles (vp) or 24 [mu]g of adenovirus protein, which appears to be the upper limit of tolerability in the animals studied, elicited strong anti-gag responses in blood samples from animals vaccinated at 0 and 24 weeks.
One such team, composed of doctors from the University of Western Ontario in London, Ont, and led by George Rice, MD, recently described their preliminary long-term safety and tolerability findings among patients treated with Betaseron.
This European single-site, double-blind, placebo-controlled multiple rising/ascending dose study is designed to test the safety, tolerability and pharmacokinetics of increasing dosages of arimoclomol in healthy volunteers over a seven-day period.
Barry Hafkin, Chief Medical Officer of Affinium Pharmaceuticals, noted, "We have previously documented good oral bioavailability and excellent tolerability of the drug candidate in two previous clinical studies using simple oral formulations, and we are very pleased to move a newly developed oral formulation that we expect will optimize the pharmacokinetic profile of AFN-1252.
Research: An open trial was conducted to assess the safety, tolerability and efficacy of oral SAM-e tosylate as an antidepressant adjunct.