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The first trial in humans of such experimental treatment is a safety trial to make sure, following successful animal tests, that there are no damaging effects.
Those include an update today on the trial in humans of a plastic stent from Abbott Laboratories that is designed to be slowly absorbed by the body instead of remaining permanently in place, as current metal stents do.
The researchers are beginning a small clinical trial in humans of a single dose of suramin that they hope will be completed by the end of the year.
We also performed the first clinical trial in humans of a polysaccharide-protein Hib conjugate vaccine.
This was the first evaluation of the effects of activation of Kv7 potassium channels on the photic-induced epileptiform reactions and the first proof of concept (POC) epilepsy trial in humans of ICA-105665.
This was the first trial in humans of an active immunotherapy approach, in which Aβ42 was introduced as an antigen to stimulate antibody production against the entire Aβ molecule, thus promoting clearance of amyloid.
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The first clinical trial in human of LNA-anti-miR (a placebo-controlled, double-blind, randomized, single dose, dose-escalating safety study of SPC3649 in a total of 64 healthy male volunteers) has been conducted by Santaris to study SPC3649 (LNA-antimiR-122; http://ClinicalTrials.gov, Identifier: NCT00688012).
DNDi is about to announce that it is ready to start trials in humans of a drug called fexinidazole.
The researcher, Dr. Craig A. Goodman, could not find any trials in humans of the additive, a substance with the tongue-twisting name of glucuronolactone that is related to glucose, a sugar.
Since conventionally prepared bispecific and bifunctional monoclonal antibodies have already shown promise in clinical trials and results from preclinical studies of recombinant bispecific antibodies are encouraging, clinical trials in humans of recombinant bispecific and bifunctional antibodies, as a new generation of biologicals, are likely to be the thrust in the next decade and beyond.
Clinical trials in humans of these live, attenuated pandemic vaccine candidates will be performed in carefully planned and executed inpatient studies.
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