first-in-human
first-in-man

The first-in-human tests of a potential treatment are called Phase I studies.

There were early safety concerns after the 'first-in-human' studies suggested high complication rates.

The Phase I first-in-human clinical trial of TRV130 is complete.

It is anticipated that the first-in-human trial of ZC-701 will be conducted in late-onset Pompe patients.

The milestone is the culmination of 600 subjects enrolled in over eight years of first-in-human biologics trials, including directly into patient experience.

The first-in-human dose-escalation trial enrolls patients with advanced and/or metastatic solid tumors whose disease is no longer considered responsive to available treatments.

This funding will enable Bexion to complete a Phase I First-in-Human clinical trial.

"We expect this program to be ready to file for first-in-human studies during the fourth quarter of 2012," Chief Medical Officer William Sheridan said.

"Nonclinical Support for First-in-Human Clinical Trials"

First-in-human trials (FIH)

For the single ascending dose part [of the clinical trial], a starting dose of 0.25 mg was judged to be safe for a first-in-human administration.

"First-In-Human Trial Designs: How Much is Too Much?"

"For powder-in-capsule (PIC) applications, the Xcelodose can drastically decrease time to clinic while also lowering the cost of drug product for first-in-human trials."

First-in-human studies have shown in vivo stability of mefway (F) and its localization to 5-HT receptor-rich regions in the human brain, including the raphe nucleus.

BI 811283 is currently in the early stages of clinical development and is undergoing first-in-human trials in patients with solid tumors and Acute Myeloid Leukaemia.

Having previously tested the drug on animals, this first-in-human clinical test has demonstrated that an efficient formula has been developed to transport and deliver RNAi with clinically promising results.

Ardea also is developing a next-generation NNRTI and a next-generation MEK inhibitor, both of which are scheduled to enter first-in-human studies in early 2008.

Precision Powder Micro-Doser and Automated Encapsulator Lowers Costs and Increases Speed to First-In-Human Trials.

In July 2014, Molecular Partners initiated a first-in-human study to investigate the safety, tolerability and blood levels of MP0250, a second DARPin candidate, in patients with cancer.

We deliver innovative and robust clinical development solutions - from first-in-human studies through market launch and surveillance - to help the world's biopharmaceutical companies maximize product life cycles and grow market share.

Emerging applications involve targeted introduction of genes or gene regulators and light (optogenetics), and by 2014, these had been at minimum demonstrated in mammalian models, or first-in-human data had been acquired.

ChemoCentryx is also advancing a second-generation, orally-active CCR9 antagonist through preclinical development and anticipates a regulatory filing to enable first-in-human studies on this compound in the second half of the year.

DESSOLVE I, the first-in-human study of the MiStent DES comprising 30 patients with documented stable or unstable angina pectoris, completed enrollment earlier this year.

This first-in-human trial is a safety and tolerability study designed to identify pharmacologically active doses and preliminary antitumor activity as well as to select the dose and schedule for Phase II trials.

The abstract is titled "Sustained Inhibition of Factor IXa by Subcutaneous RB006 with Active Reversal: First-in-Human Experience with the REG2 System."

Its drug development program has conducted 70+ "first-in-man" trials.

The trial was a "first-in-man" study of a new immunotherapy for leukaemia and rheumatoid arthritis.

The main goals of pre-clinical studies are to determine the safe dose for First-in-man study and start to assess product's safety profile.

"We are aiming to achieve first-in-man readiness no later than the beginning of 2013, which girds this program with first-in-class potential."

This Phase I trial is a first-in-man study with a focus to obtain safety and immunogenicity data in a small population of healthy adults.

It reported that the European guidelines for first-in-man phase-I clinical trials of biologics had been revised.

Stages of in vitro and in vivo research are conducted to determine safe doses of exposure in humans before a first-in-man study.

Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: a first-in-man study.

Arisaph filed an IND for ARI-2243 during the first quarter of 2008 and has initiated a first-in-man safety study in healthy volunteers.

The compound, called slit-trap, was developed by its Chinese collaborator, Shanghai Institutes of Biological Sciences, and will soon be ready for a "first-in-man" trial.

In the second chapter, the book describes the process as new drugs move from animal testing through phase 1 (first-in-man study), phase 2, and phase 3 clinical trials.

The protocol presents a summary of what appears to be a full package of pharmacodynamic, pharmacokinetic and toxicological studies that might be expected to support a first-in-man study.

The CUSTOM I trial is a 30-patient first-in-man study designed to evaluate the preliminary safety and feasibility of in-situ stent customization.

(Vancouver), a global specialty pharmaceutical and medical device company, announced the results from its European first-in-man study for its Vascular Wrap(TM) paclitaxel-eluting product.

This first-in-man study is designed to evaluate the safety and performance of a novel and proprietary drug-loaded Vascular Wrap in the prevention of stenosis after peripheral bypass surgery.

An antisense oligonucleotide against SOD1 delivered intrathecally for patients with SOD1 familial amyotrophic lateral sclerosis: a phase 1, randomised, first-in-man study.

The Clinical Neuroscience Research grants support researchers testing promising therapies that move from animal models to a small number of human patients with devastating, currently untreatable brain diseases (first-in-man studies).

A first-in-man study is a clinical trial where a medical procedure, previously developed and assessed through in vitro or animal testing, or through mathematical modelling is tested on human subjects for the first time.

The company's lead product candidate for hearing loss and balance disorders, partnered with Novartis, is in a first-in-man gene delivery Phase 1/2 clinical trial in patients with severe to profound hearing loss.

First-in-Man Trial of an RNA Interference Therapeutic Targeting VEGF and KSP in Cancer Patients with Liver Involvement.

Dishwasher Pete also volunteered as a "human guinea pig" in first-in-man drug trials, and contributed articles to the Guinea Pig Zero: A Journal for Human Research Subjects zine.

Furthermore, special attention will be given to the discussion of how comprehensive initiatives for addressing critical regulatory issues in first-in-man phase I clinical studies can potentially improve the efficiency and quality of biomedical and translational research at an international level.

The NVCI carried out the first ever first-in-man clinical trials in the state of Nevada as well as seminal clinical trials making previously unavailable early-stage clinical trial therapies available to the over 15,000 patients served.

TGN1412 (also known as CD28-SuperMAB and TAB08) was the working name of an immunomodulatory drug which was withdrawn from development after inducing severe inflammatory reactions in the first-in-man study in London in March 2006.

The First-in-man study Phase I clinical trials were conducted by Parexel at an independent clinical trials unit in leased space on the premises of Northwick Park and St. Mark's Hospital, London, on 13 March 2006.