Trial · Interventional
CompletedPhase 1Registry dataSafety Study of NNZ-2566 in Healthy Female Subjects
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 39 participants (actual)
- Sponsor
- Neuren Pharmaceuticals Limited · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
Australia
- Start
- Mar 2010
- Primary completion
- Aug 2010
- Completion
- Sept 2010
- First posted
- 19 Aug 2009 (estimated)
- Last update posted
- 7 Oct 2014 (estimated)
- Conditions
- Brain Injuries, Traumatic
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female volunteers.
Interventions
- NNZ-2566Drug
- PlaceboDrug
Arms2
Placebo comparator
Placebo (Normal saline infusion)
Experimental
NNZ-2566
NNZ-2566 reconstituted in bicarbonate buffer and normal saline. 6/8 subjects in each cohort (5 cohort in total) to receive NNZ-2566 experimental treatment.
Primary outcomes1
Outcomes the sponsor listed as primary.
Incidence of AEs and SAEs
Time frame · Through to Day 7 post end of study drug infusion or until resolved
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 50 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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