Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration
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|ClinicalTrials.gov Identifier: NCT01420042|
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : November 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries, Traumatic||Drug: NNZ-2566 Drug: Placebo||Phase 1|
Double-blind, placebo-controlled, randomized (with a 6:2 randomization for active versus placebo) safety, dose-escalation, and pharmacokinetic study of NNZ-2566.
Three cohorts will be sequentially dosed, starting with two cohorts receiving a single dose (6mg/kg followed by 30mg/kg). The third cohort will receive two 100mg/kg doses over the course of one day and following a formal safety review the same subjects will then receive two 100mg/kg doses each day for five days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of NNZ-2566 in Healthy Subjects, Following Oral Administration|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||September 2012|
Placebo Comparator: Placebo (lemon flavoured cordial)
NNZ-2566 reconstituted in Lemon flavoured cordial and Water for Injection. 6/8 subjects in each cohort (3 cohorts in total) to receive NNZ-2566 experimental treatment.
Lemon flavoured cordial and Water for Injection
Other Name: Bickford's Bitter Lemon Cordial, 1:1 in Water for Injection
Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with lemon flavoured cordial and Water for Injection.
Other Name: NNZ-2566 Lot NNZP25
- Incidence of adverse events (AE) and serious adverse events (SAE) [ Time Frame: Through to Day 7 post end of study drug administration or until resolved ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420042
|Melbourne, Victoria, Australia|
|Principal Investigator:||Maggie Scott||Neuren Pharmaceuticals Ltd|