A phase 1, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose study to evaluate the safety, tolerability, and pharmacokinetics of intravenous CMX-020 in healthy male and female subjects
Cytometix Inc
48 participants
Jan 10, 2018
Interventional
Conditions
Summary
This is a Phase I, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose, single-center study to evaluate the safety and tolerability, and describe the pharmacokinetics of escalating single doses of CMX-020 administered as a 15-minute intravenous infusion to healthy male and female subjects. The study population will be comprised of up to 48 healthy male and female subjects aged 18-50 years, inclusive, considered eligible on the basis of study inclusion and exclusion criteria. Each subject who meets eligibility criteria will be randomly assigned to receive CMX-020 or placebo. Each escalating dose group will consist of 8 subjects; 6 will be randomized to receive a single dose of CMX-020, and 2 will be randomized to receive a single dose of placebo. Treatment groups will be dosed in an escalating order, each dose level increased by no more than 2-fold over the previous dose level. The decision to escalate the dose will be based upon review of the safety and EEG data for all subjects in each previous dosing panel. No subject will receive more than one dose of study medication.
Eligibility
Inclusion Criteria6
- Healthy adult male or adult female between the ages of 18-50 years in good physical health.
- Of non-childbearing potential or using an acceptable form of contraception
- Weigh at least 50 kg, and no more than 90and have a body mass index (BMI) between 18 and 32 kg/m2
- Clinical laboratory results (including clinical chemistry, hematology, and urinalysis) within the reference range for the testing laboratory
- Negative tox, hepatitis and HIV screens
- Creatinine clearance of at least 70 mL/min
Exclusion Criteria8
- Any subject who meets any of the following criteria will not qualify for entry into the study:
- History of drug abuse, cancer, liver disease, seizure, metabolic disease or head trauma
- Systolic blood pressure > 140 mm Hg or < 90 mm Hg, or diastolic blood pressure > 90 mm Hg during the Pretreatment Screening or Baseline/Check-in Periods
- Pulse > 100 beats/minute or < 50 beats/minute during the Pretreatment Screening or Baseline/Check-in Periods
- Pulse oximetry values <95% on room air; temperature <35.8°C and >37.5°C
- Clinically significant abnormal ECG at Pretreatment Screening or Baseline/Check-in Periods or history of Long QT Syndrome
- Clinical laboratory values within the normal limits as defined by the clinical laboratory, unless the investigator decides that out-of-range values are not clinically significant
- Recent use of alcohol, tobacco, prescription or OTC medications
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Interventions
Up to six (6) dose levels with approximately two weeks between the dosing of each group. In total of 6 cohorts: Cohort 1: CMX-020 drug- 0.02 (mg/kg) - Single Intravenous infusion over 15 min Cohort 2: CMX-020 drug- 0.04 (mg/kg) - Single Intravenous infusion over 15 min Cohort 3: CMX-020 drug- 0.08 (mg/kg) - Single Intravenous infusion over 15 min Cohort 4: CMX-020 drug- 0.16 (mg/kg) - Single Intravenous infusion over 15 min Cohort 5: CMX-020 drug- 0.24 (mg/kg) - Single Intravenous infusion over 15 min Cohort 6: CMX-020 drug- 0.32 (mg/kg) - Single Intravenous infusion over 15 min Each escalating dose group will consist of 8 subjects; 6 will be randomized to receive a single dose of CMX-020, and 2 will be randomized to receive a single dose of placebo.
Locations(1)
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ACTRN12617001583336