None listed
Conditions
Brief summary
This is a Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Ascending Single-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of CMX-020 In Healthy Male and Female Subjects.
Interventions
Each subject who meets eligibility criteria will be randomly assigned to receive CMX-020 or placebo.
The study will consist of Screening (Day -28 to Day -1), Baseline/Check-in Period (Day 1), Treatment Period (Day 1) and Post Treatment/Study Exit (Day 4).
Following randomization, on Treatment Day 1 subjects will be administered a single 15-minute infusion of CMX-020 or placebo according to the computer-generated randomization schedule. All doses will be administered after subjects have fasted f
Each subject who meets eligibility criteria will be randomly assigned to receive CMX-020 or placebo. The study will consist of Screening (Day -28 to Day -1), Baseline/Check-in Period (Day 1), Treatment Period (Day 1) and Post Treatment/Study Exit (Day 4). Following randomization, on Treatment Day 1 subjects will be administered a single 15-minute infusion of CMX-020 or placebo according to the computer-generated randomization schedule. All doses will be administered after subjects have fasted for at least six hours. Access to all fluids, including water, will be denied beginning 1 hour prior to dosing. The dose levels of CMX-020 (mg/kg) for the six cohorts are 0.02, 0.04, 0.08, 0.16, 0.24 and 0.32. All medications will be administered by the Investigator or appropriately trained healthcare professional in the clinical study unit.
Sponsors
Cytometix Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
- The subject is a healthy adult male or adult female between the ages of 18-50 years, inclusive. - The subject must weigh at least 50 kg and no more than 90 kg and have a body mass index (BMI) between 18 and 32 kg/m2, inclusive - The subject must be in good health as determined by a physician. If female, must have a negative urine pregnancy test result at the Screening Visit, and be non-lactating
Exclusion criteria
- The subject has a history of drug abuse or a history of alcohol abuse within the past 2 years - The subject has systolic blood pressure > 140 mm Hg or < 85 mm Hg, or diastolic blood pressure > 90 mm Hg or < 60 mm Hg during the Pretreatment Screening or Baseline/Check-in Periods - The subject has a pulse > 100 beats/minute or < 55 beats/minute during the Pretreatment Screening or Baseline/Check-in Periods - The subject has active liver disease, jaundice, or an alanine transaminase (ALT) level or aspartate transaminase (AST) level of greater than 1.5 times the upper limit of normal (ULN) during the Pretreatment Screening or Baseline/Check-in Periods
Outcome results
None listed