ascending dose study

ascending dose study

A component of a phase-I clinical trial in which increasing doses of a drug are administered until the maximum tolerated dose is reached.
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Rebecca Cousins, lead research nurse for the trial said: "This trial has set a number of firsts for Huntington's disease - the first 'in man' study for ISI443139, the first intrathecal delivery of this drug in Huntington's disease and the first multiple ascending dose study in Huntington's disease.
The Phase 1 study, designed to enroll up to 52 healthy volunteers, is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study intended to evaluate the safety and tolerability of PL-8177 administered via subcutaneous injection.
ASPIRO is a multicenter, multinational, open-label, ascending dose study to evaluate the safety and preliminary efficacy of AT132 in approximately twelve XLMTM patients less than five years of age.
Up to 80 healthy volunteers will be enrolled in this double-blind, placebo controlled phase 1 single ascending dose study to evaluate the safety and pharmacokinetics of LT3001, results from the phase 1 study will determine the doses for subsequent clinical studies in stroke patients, added the company.
This Phase 1 programme includes 2 clinical studies-- a single ascending dose study and a multiple ascending dose study-and is expected to be complete in 2016", informed Dr Murray.
A lead H4 antagonist has completed a Phase 1 multiple ascending dose study.
The two E2609 Phase I studies presented at the AAIC 2012 comprised a single oral ascending dose study (Study A001-001) which showed Abeta levels reduction in plasma, and a 14-day multiple oral ascending dose study (Study A001-002) which showed dose-dependent increase of E2609 PK level and statistically significant reduction of Abeta levels in cerebrospinal fluid (CSF).
In a standard single ascending dose study, it is not difficult to compile the safety information quickly between cohorts.
Data from this single and multiple ascending dose study demonstrated that CH-4051 is safe and well tolerated up to a maximally tolerated dose of 7.
Eight patients, five men and three women aged 25-40 years, were recruited for a placebo-controlled, balanced, ascending dose study, in which all patients received one oral dose of 0.
The Phase I program consisted of a comprehensive single and multiple ascending dose study in healthy volunteers and a subsequent human pharmacodynamic study to assess the ability of NOX-H94 to prevent endotoxin-induced hypoferremia in healthy subjects.
Pending approval, Arrowhead intends to proceed with AROAAT1001, a Phase 1 single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and effect of ARO-AAT on serum alpha-1 antitrypsin levels in healthy adult volunteers.