Safety Study of NNZ-2566 in Healthy Female Subjects
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability and PK of NNZ-2566 in Healthy Females, When Administered as a Loading Dose (10-Min), and as a Loading Dose Followed by a Maintenance Dose (72-Hr).|
- Incidence of AEs and SAEs [ Time Frame: Through to Day 7 post end of study drug infusion or until resolved ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2010|
|Study Completion Date:||September 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo (Normal saline infusion)||
Normal saline infusion
Other Name: Sodium Chloride 0.9% Injection
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.
Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with bicarbonate buffer and normal saline.
Other Name: Experimental name: NNZ-2566
To obtain evidence of the safety of NNZ-2566 in healthy female volunteers, compared to placebo when administered as a 10 minute intravenous (i.v.) bolus infusion, and when administered as a 10-minute bolus infusion immediately followed by a continuous 72-hour maintenance infusion.
To determine the blood pharmacokinetics (PK) of an intravenous dose of NNZ-2566 in healthy female volunteers when administered as a 10-minute bolus infusion, and when administered as a 10-minute bolus followed by a continuous 72-hour maintenance infusion.
|Melbourne, Victoria, Australia, 3004|
|Study Director:||Douglas J Wilson, MB ChB, PhD||Neuren Pharmaceuticals Ltd|