WHO ICTRP trial

A double-blind Phase I study to investigate safety, tolerability, and…

ACTRN12616001437459 · Australian New Zealand Clinical Trials Registry (ANZCTR) · Not Recruiting

Key facts

Trial ID ACTRN12616001437459
Public title A double-blind Phase I study to investigate safety, tolerability, and pharmacokinetics of single and repeated escalating doses of EU-C-001 given as intravenous infusions and as oral administrations in healthy male subjects
Scientific title A double-blind Phase I study to investigate safety, tolerability, and pharmacokinetics of single and repeated escalating doses of the NK1 receptor antagonist EU-C-001 given as intravenous infusions and as oral administrations in healthy male subjects
Primary sponsor PresSura Neuro Ltd
Registry Australian New Zealand Clinical Trials Registry (ANZCTR)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 1
Countries Australia
Conditions Traumatic brain injury; Traumatic brain injury;Neurological - Other neurological disorders
Interventions EU-C-001: Group 1: Single oral administration (5mg, 15mg, 45mg, 90mg, 150mg, 180mg) Each subject will receive one single oral administration of the study medication, either EU-C-001 or placebo. At each dose levels, six male subjects will…
Registration date Oct 14, 2016
Target size 114
Secondary IDs Nil known
Registry page anzctr.org.au

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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