None listed
Conditions
Brief summary
Neural Regeneration Peptide 2945 (NRP2945) is an experimental drug being developed by CuroNZ Pty. Ltd for the potential treatment of severe childhood-related refractory epilepsy such as Lennox-Gastaut Syndrome (LGS). In animal models, NRP2945 has been shown to be a driver molecule in central nervous system (CNS) neural regeneration processes during stages of disease or injury. In this first time in human study, single ascending doses and multiple ascending doses of NRP2945 will be assessed in healthy male volunteers. NRP2945 will be administered by subcutaneous injection in the abdomen. Assessments of safety, tolerability, pharmacokinetics and pharmacodynamics parameters following administration of NRP2945 will guide decisions to further develop the drug.
Interventions
NRP2945 (0.64mg/mL net peptide weight) is formulated in 0.4% PEG (MW 3000-3200), 1% mannitol, 0.5 M D(+)-Trehalose in 20mM sodium citrate (pH 4.5).
In Part 1, it will be administered as a single dose by subcutaneous bolus injection in the lower abdomen (anyone of the 4 quadrants may be used for the injection).
In Part 2, multiple doses will be injected in the 4 quadrants of the lower abdomen over a period of 27 days every second day starting from Day 1. All 4 quadrants will be used for each su
NRP2945 (0.64mg/mL net peptide weight) is formulated in 0.4% PEG (MW 3000-3200), 1% mannitol, 0.5 M D(+)-Trehalose in 20mM sodium citrate (pH 4.5). In Part 1, it will be administered as a single dose by subcutaneous bolus injection in the lower abdomen (anyone of the 4 quadrants may be used for the injection). In Part 2, multiple doses will be injected in the 4 quadrants of the lower abdomen over a period of 27 days every second day starting from Day 1. All 4 quadrants will be used for each subject. Two injections will be given if the volume to be administered is more than 2mls. Part 1: Single ascending dose cohorts; doses to be administered are 1.0, 3.0, 10.0 and 25.0 microgram/kg. Part 2: Multiple ascending dose cohorts – 3 doses will be administered and will be determined by a data monitoring committee after completion of the SAD cohorts in Part 1.
Sponsors
CuroNZ Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent 2. Males aged 18 - 45 years inclusive on the day of consent 3. Healthy on the basis of medical history and screening assessments, in the opinion of the Investigator 4. BMI 20 – 30 kg/m2 inclusive 5. Use of contraception for 90 days from the start of study drug administration. Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for 90 days post treatment. 6. Agree to fulfil all of the requirements of the study 7. No alcohol is to be consumed from 24 hours prior to the time of pre-dose admission until after the final follow-up visit is completed. 8. Participants will be asked to refrain from strenuous exercise the day before screening and during the day prior to admission for dosing.
Exclusion criteria
1. Clinically significant co-existing disease or condition in the opinion of the Investigator (example of an allowable condition is hay fever that does not require regular medication). 2. Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C; 3. Infection or febrile illness within 5 days prior to first dose 4. Haemoglobin or haematocrit below the laboratory reference range 5. Raised blood pressure (systolic >140 mmHg or diastolic >95 mmHg) 6. Current or previous clinically significant smoking history (i.e. more than 2 cigarettes per day in the last 12 months) 7. Any prescribed medications within 14 days prior to the first dose of study medication 8. Any over-the-counter medications/herbal remedies/vitamins/supplements within 7 days prior to first dose of study medication 9. Use of any investigational drug within 30 days of dosing, or planned use of another investigational drug during the course of this study 10. History of prolonged QT interval, or prolonged QTcF interval at screening, defined as QTcF >450 msec (the average of the triplicate should be used to assess QTcF). 11. Positive results for urine drugs of abuse screen or alcohol breath test at screening 12. Any illegal or non-approved recreational drug use during the last six months.
Outcome results
None listed