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Trial details imported from ClinicalTrials.gov
Ethics application status
Safety Study of NNZ-2566 in Healthy Female Subjects
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).
Universal Trial Number (UTN)
Brain Injuries, Traumatic
Injuries and Accidents
Other injuries and accidents
Other neurological disorders
Description of intervention(s) / exposure
Treatment: Drugs - NNZ-2566
Treatment: Drugs - Placebo
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.
Treatment: Drugs: NNZ-2566
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.
Treatment: Drugs: Placebo
Normal saline infusion
Intervention code 
Comparator / control treatment
Primary outcome 
Incidence of AEs and SAEs
Through to Day 7 post end of study drug infusion or until resolved
Key inclusion criteria
- Aged between 18 years and 50 years (inclusive).
- Females only.
- Weight 50 to 105 kg
- BMI of 18 to 30 kg/m2.
- General Health: Healthy, determined by a medical history with particular attention to:
- a drug history identifying any known drug allergies and the presence of drug
- any chronic use of medication; and
- a thorough review of body systems. This will also be determined by having no
clinically significant abnormal findings on physical examination, which includes
an electrocardiogram (ECG), which in the opinion of the Investigator would
jeopardize the safety of the subject or impact on the validity of the study
- Venous Access: Volunteers with adequate venous access in their left and right arm to
allow collection of blood samples and drug administration.
- Language: Fluent in the English language.
- Informed Consent: Have voluntarily given written informed consent to participate in
Can healthy volunteers participate?
Key exclusion criteria
- Pregnant and lactating females are excluded from participating in the study.
- History of allergy and/or hypersensitivity to any of the stated ingredients of the
- History of clinically significant gastrointestinal, hepatic, renal, cardiovascular,
dermatological, immunological, respiratory, endocrine, oncological, neurological,
metabolic, psychiatric disease or hematological disorders.
- Any history of asthma during the last 10 years.
- A creatinine clearance of less than 75 mL/min.
- Any predisposing condition that might interfere with the absorption, distribution,
metabolism, and/or excretion of the investigational product.
- History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture
or intravenous cannulation.
- History of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of
Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or
demonstration of HIV antibodies.
- Any evidence of organ dysfunction, or any clinically significant clinical laboratory
value, including a liver function test (LFT) > 1.5 x upper limit of normal (ULN).
- Difficulty abstaining from alcohol during the 48 hours prior to dose administration
and until completion of blood sampling at exit assessment.
- History of, or current evidence of, abuse of alcohol or any drug substance, licit or
illicit, or positive urine drug screen for drugs of abuse.
- Difficulty in abstaining from any prescription medications for 14 days prior to dose
administration and for the duration of the study.
- Difficulty in abstaining from over-the-counter (OTC) medications or herbal supplements
for 14 days prior to dose administration and for the duration of the study, (with the
exception of occasional analgesia, vitamin and other nutrient supplement use, at the
discretion of the Investigator).
- Difficulty in abstaining from food and/or beverages that contain caffeine or other
xanthines, (e.g., coffee, tea, cola and chocolate) during the 24 hours prior to dose
administration and whilst confined at the clinical study facility.
- History of any psychiatric illness which may impair the ability to provide written
- Poor protocol compliers or those unlikely to attend.
- Receipt of any drug as part of a research study within 30 days of initial dose
administration in this study.
- Standard blood donation (usually 550 mL) within the 12-week period before dose
- Unusual dietary habits and excessive or unusual vitamin intakes.
- Vaccination or immunizations within 30 days of initial dose administration.
- QT/QTc Exclusions i.e., a marked baseline prolongation of corrected QT interval > 450
ms in two ECGs, or a history of risk factors for Torsade de Pointes (e.g., heart
failure, hypokalemia, family history of Long QT Syndrome).
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Nucleus Network - Melbourne
Recruitment postcode(s) 
Primary sponsor type
Neuren Pharmaceuticals Limited
Ethics application status
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
Trial related presentations / publications
Douglas J Wilson, MB ChB, PhD
Neuren Pharmaceuticals Ltd