None listed
Conditions
Brief summary
This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given as an intravenous infusion to healthy volunteers. The study will look at the study drug’s safety and tolerability when given as a single dose at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the dosing periods, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream).
Interventions
DUR-928 (powder for constitution): 30 mg/mL DUR-928 solution after constitution with sterile vehicle solution.
Placebo: sterile vehicle solution. The sterile vehicle solution contains hydroxypropyl betadex in phosphate buffered water.
Each subject will receive a single dose of either active DUR-928 or placebo. The constituted DUR-928 solution, or placebo vehicle, is appropriately diluted with glucose 5% intravenous solution to prepare the infusion solution. The dose will be administered via int
DUR-928 (powder for constitution): 30 mg/mL DUR-928 solution after constitution with sterile vehicle solution. Placebo: sterile vehicle solution. The sterile vehicle solution contains hydroxypropyl betadex in phosphate buffered water. Each subject will receive a single dose of either active DUR-928 or placebo. The constituted DUR-928 solution, or placebo vehicle, is appropriately diluted with glucose 5% intravenous solution to prepare the infusion solution. The dose will be administered via intravenous (IV) infusion. The doses of the intervention are described below per cohort: Cohort 1: 50 mg/100 mL DUR-928 or placebo (vehicle solution) administered over 2 hours via IV infusion Cohort 2: TBD* mg/100 mL of DUR 928 or placebo (vehicle solution) administered over 2 hours via IV infusion *Note: Dose level for Cohort 2 will be determined after review of safety, tolerability, and pharmacokinetic data of Cohort 1 and will not exceed 300 mg. Study participants will take part in only one cohort. All study participants will be confined to the study unit for the treatment period. Study staff will administer all doses.
Sponsors
INC Research
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Be in good health as determined by medical history, physical examination, 12 lead ECG and clinical laboratory evaluations at screening; Weight at least 50kg and BMI between 18.0 kg/m2 and 30.0 kg/m2, inclusive; Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed; Female subjects must be of non-childbearing potential; Willing and be able to be admitted to the clinical study unit for 3 nights and 2 days; Able to abstain from alcohol and tobacco use during the trial.
Exclusion criteria
Significant blood loss or donated blood in the 30 days prior to study participation Participation in an investigational drug study within 30 days prior to dosing. History of drug or alcohol abuse. Use of any medications, including OTC and herbal or nutritional supplements during the week prior to drug dosing Positive tests for HIV, hepatitis B/C, drugs of abuse or alcohol breath-test. Clinically significant abnormalities
Outcome results
None listed