None listed
Conditions
Brief summary
This is a phase I trial to assess the safety and tolerability of a new anti-anxiety drug over a wide range of doses. This will enable doses, that are safe and produce good levels of drug in the body, to be selected for further studies in which measurement of anti-anxiety activity may be done.
Interventions
Each participant will receive a single oral dose of BNC210. The dose will be administered as a suspension in 10 mL of vehicle. The starting dose will be 5 mg, with 3-fold escalations up to 150 mg, which will be doses of 5, 15 and 50 mg and 150 mg, then 2 fold escalations thereafter with doses of 300, 600 and 1200 mg.
Sponsors
Bionomics Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the principal investigator. 2. Good general mental health as determined by scores on the Symptom Checklist-90-R (SCL-90-R (registered trademark)), a screening instrument which evaluates a broad range of psychological problems and symptoms of psychopathology. 3. Agree to and be capable of signing informed consent form. 4. Have suitable venous access for blood sampling. 5. Body Mass Index within the range of 19-30 kg/m2.
Exclusion criteria
1. Renal impairment as evidenced by estimated creatinine clearance, measured by the Cockcroft-Gault method of less than 90 mL/min. 2. Have a laboratory value at the Screening Visit that is outside the normal range, unless it is judged by the Investigator as not clinically significant after appropriate evaluation. 3. A score of more than two standard deviations from the mean on any of the key nine scales in the SCL-90-R (registered trademark) 4. Any medical condition that in the opinion of the investigator may adversely impact on the participant’s ability to complete the study. 5. Plasma Aspartate transaminase (AST), Alanine transaminase (ALT), and Alkaline phosphatase (ALP) tests in excess of 1.5 times the upper limit of normal. 6. History of severe allergic or anaphylactic drug-related reactions. 7. Current (within the last six months) clinically significant psychiatric disorder including anxiety or depression. 8. Concurrent use of other medication on a regular or daily basis. 9. Participation in another clinical trial of an investigational agent within 30 days of study entry. 10. Known history of past or present infection with hepatitis C virus (HCV), hepatitis B or human immunodeficiency virus (HIV). 11. Clinically significant abnormal electrocardiogram (ECG) (12-lead) at the screening visit or prior to dosing on Day 1, as determined by the Investigator. 12. Subjects who have a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc interval >450 msec for females or >430 msec for males) at screening or prior to dosing on Day 1 will not be allowed to continue in the study. 13. Significant history of illicit drug or alcohol use or abuse (as determined by the Investigator) within 1 year of the Screening Visit. 14. Any alcohol use within 24 hours prior to dosing on Day 1. 15. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits on schedule. 16. Blood donation (1 unit or more) within 1 month prior to the screening visit. 17. Smoke >5 cigarettes per day.
Outcome results
None listed