A Single and Multiple Daily Injection Study of DUR-928 in Healthy Volunteers.
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of DUR 928 Administered Intramuscularly (IM) in Healthy Volunteers
INC Research
44 participants
Aug 25, 2015
Interventional
Conditions
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 intramuscular injection to healthy volunteers. The study will look at the study drug’s effect when given as a single dose at 4 different dose levels, and then once daily for 5 days 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).
Eligibility
Inclusion Criteria5
- Be in good health as determined by medical history, physical examination, 12 lead ECG and clinical laboratory evaluations at screening;
- 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 4 days if enrolled in Part A, or 7 nights and 8 days if enrolled in Part B;
- Able to abstain from alcohol and tobacco use during the trial.
Exclusion Criteria6
- 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
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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. In Part A, each subject will receive a single dose of either active DUR-928 or placebo according to the Cohort they are participating in and the intervention they are randomised to. The dose will be administered intramuscularly in the subject’s gluteal muscle (buttocks).The doses of the intervention are described below per cohort: Cohort 1: 1.0 mL of 30 mg/mL (30 mg) DUR-928 or placebo Cohort 2: 3.0 mL of 30 mg/mL (90 mg) DUR-928 or placebo Cohort 3: 5.0 mL of 30 mg/mL (150 mg) DUR-928 or placebo Cohort 4: 10.0 mL of 30 mg/mL (150 mg) DUR-928 or placebo In Part B, each subject will receive 5 daily doses of either active DUR-928 or placebo according to the Cohort they are participating in and the intervention they are randomised to. The doses will be administered intramuscularly in the subject’s gluteal muscle (buttocks) once daily for 5 days, alternating sides for injection sites. Doses for Cohort 1 and 2 in Part B will be determined after review of safety and PK data from Part A of the study. Cohort 1: 5.0 mL of 30 mg/mL DUR-928 or placebo Cohort 2: x.x mL of 30 mg/mL DUR-928 or placebo Study participants will take part in only one cohort, in either Part A or Part B. During Part A and Part B, all study participants will be confined to the study unit for the treatment period. Study staff will administer all doses.
Locations(1)
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ACTRN12615000903583