None listed
Conditions
Brief summary
This study is investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single ascending dose of BW-20805 in healthy volunteers in 4 dose level cohorts. Approximately 32 men and women aged (more than equal to) 18 to (less than equal to) 60 years who fulfill the inclusion and exclusion criteria will be enrolled at one site in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 (24 hours post-dose), and return for outpatient visits through Week 24. Within each cohort, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of BW-20805 (n=6) or placebo (n=2) on Day 1 in a double-blind fashion. Cohorts 1 to 4 and the control group will receive BW-20805 doses of 50mg, 150mg, 300mg, and 600mg, or placebo respectively.
Interventions
BW-20805 is a clear, colorless to yellow solution. It will be supplied as a sterile 200 mg/1mL solution for subcutaneous (SC) injection. BW-20805 (50mg, 150mg, 300mg, 600 mg) or matching placebo (sodium chloride injection, 0.9% w/v) will be administered as SC injection(s).
This study will consist of 4 separate and sequential dose cohorts. Within each cohort, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of BW-20805 (n=6) or placebo (n=2). The population in Cohort 1 to 4 w
BW-20805 is a clear, colorless to yellow solution. It will be supplied as a sterile 200 mg/1mL solution for subcutaneous (SC) injection. BW-20805 (50mg, 150mg, 300mg, 600 mg) or matching placebo (sodium chloride injection, 0.9% w/v) will be administered as SC injection(s). This study will consist of 4 separate and sequential dose cohorts. Within each cohort, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of BW-20805 (n=6) or placebo (n=2). The population in Cohort 1 to 4 will include healthy subjects. - Cohort 1: 50 mg BW-20805 or placebo - Cohort 2: 150 mg BW-20805 or placebo - Cohort 3: 300 mg BW-20805 or placebo - Cohort 4: 600 mg BW-20805 or placebo Each cohort will firstly enroll a sentinel group of 2 subjects, of which one will receive BW-20805 and the other will receive placebo in a double-blind fashion. If deemed safe and tolerated by the Investigator, the remaining subjects in the same cohort will be dosed after the 2nd sentinel subject through 48 hours post dosing. Dose escalation will be based on the Safety Review Committee (SRC) assessment. The doses will be administered by the study nurse(s) or trained staff at site. Accurate records will be kept by the unblinded pharmacy personnel or designee(s) of when and how much study drug is dispensed and used by each subject in the study. Any reason for departure from the protocol-specified dispensing regimen must also be recorded. Destruction and return should also be recorded. Study drug accountability records will be maintained by the unblinded pharmacy personnel or designee(s) in a secure location. Drug accountability records will be available for verification by Argo Biopharma personnel or designee.
Sponsors
Argo Biopharma Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must have given written informed consent and be able to comply with all study requirements. 2. Males or females aged 18 to 60 aged years, inclusive, at the time of informed consent. 3. BMI (more than equal to) 18 and (less than equal to) 32 kg/m2 with body weight >50 kg.
Exclusion criteria
1. Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters that, in the opinion of the investigator, makes the subject unsuitable for participation in the study. 2. Hospitalization for any reason within 60 days prior to screening. 3. Any clinically significant acute condition such as fever (>38 degree centigrade) or acute respiratory illness within 7 days of study drug administration. 4. Systolic blood pressure (more than equal to) 140 mmHg and/or diastolic blood pressure (more than equal to) 90 mmHg after at least 5 minutes resting (seated or supine) at screening and Day -1. 5. Any liver function panel analyte value greater than upper limits of normal (ULN) which includes aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin (TBIL), and alkaline phosphatase (ALP) at screening and Day -1. 6. International normalized ratio (INR) above 1.2 × ULN at screening and Day -1. 7. Triplicate 12-lead electrocardiogram (ECG) with clinically significant abnormalities at screening and Day -1, as determined by the clinical investigator. 8. History or clinical evidence of alcohol abuse, within the 12 months before screening. 9. History or clinical evidence of drug abuse, within the 12 months before screening. 10. Donated or lost >200 mL of blood within 30 days prior to screening.
Outcome results
None listed